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Pharmazie: 20 Jobs in Forstinning

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Pharmazie

Associate Regulatory Affairs - EU Regulatory Procedural Management (m/f/x)

Mi. 19.01.2022
München
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For our headquarter in Munich we are seeking highly qualified candidates to fill the position of Associate Regulatory Affairs - EU Regulatory Procedural Management (m/f/x) Provide support for EU Regulatory Procedural Management for assigned projects including all pre- and post-authorisation activities ensuring a smooth run of regulatory procedures as well as regulatory compliance. Act as a representative at project teams assigned, working with EU regulatory strategy leads, with affiliates, license partners and others to support procedural delivery of the projects. Roles and responsibilities: Support assigned regulatory submissions during development and life cyclemanagement, in alignment with regulatory strategists, for European and other assigned non-EU authorities Serve as a link between regulatory strategists, product support, and otherdisciplines in RA (e.g. RA-CMC, Labelling, Regulatory Operations, Clinical TrialOffice) As assigned, represent EU regulatory procedural management in global regulatory and development teams and provide EU regulatory procedural guidance and operational strategy for assigned projects As assigned by manager, act as the regulatory contact person for authorities pertinent to procedural matters Support internal communications on regulatory status for the assigned assets Ensure consistency across projects and global alignment/synergies Participate in assigned non-project tasks designed to enhance the operations and processes of Regulatory Affairs Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives University degree in Pharmacy, Life Sciences, Natural Sciences or Medical Science, Master preferred; Master degree in Regulatory Affairs is a plus Minimum of 1-2 years of experience in Regulatory Affairs; experience with EMA and CAPs is a plus Experience of working in a global environment in interdisciplinary teams Proven ability to plan, coordinate and lead activities simultaneously on multiple projects Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner Solution and detail-oriented; well organised and self-motivated Strong working knowledge of Microsoft Office Excellent written and oral communication skills in English, second EU language preferred Competitive Pay Work-Life-Balance Growth and Development Health and Family Working at Daiichi Sankyo: At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
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National Market Access Manager Oncology (m/w/d)

Mi. 19.01.2022
München
Unsere 16.000 Mitarbeiter*innen in mehr als 20 Ländern engagieren sich für die Entwick­lung und den Vertrieb innovativer pharma­zeutischer Produkte. In Europa konzentrieren wir uns auf zwei Bereiche: Unser starkes kardiovaskuläres Arzneimittel­portfolio spiegelt unser lang­jähriges Engagement in diesem Bereich wider und zeigt, dass für uns jeder Herzschlag zählt. Mit dem Ziel, ein globaler Pharma-Innovator in der Onkologie zu werden, wollen wir Patient*innen auf der ganzen Welt neuartige onkologische Therapien zur Verfügung stellen. Unser euro­päischer Haupt­sitz befindet sich in München, Deutschland, und wir haben Nieder­lassungen in 13 euro­päischen Ländern. Ab dem 01.04.2022 suchen wir bei der Daiichi Sankyo Deutschland GmbH eine/n engagierte/n Kandidaten/in für die Rolle als National Market Access Manager Oncology (m/w/d) In Ihrer Funktion berichten Sie an den Director Market Access Oncology und sind mit folgenden Hauptaufgaben betraut: Leitung cross-funktionaler Projektteams zur Erstellung von Dossiers zur Nutzenbewertung nach § 35a SGB V (AMNOG-Dossiers) einschließlich Stellungnahmeverfahren und Teilnahme Anhörung Vorbereitung und Teilnahme an Preisverhandlungen nach §130b SGB V mit dem GKV-SV Zusammenarbeit mit dem europäischen Headquarter, um spezifische Anforderungen des deutschen HTA-Systems zu kommunizieren, z.B. Studiendesign, Endpunkte, statistische Analysen für bestmöglichen Market Access inkl. Vorbereitung und Durchführung von G-BA Beratungsgesprächen Erarbeitung und Umsetzung einer nationalen Market Access Strategie unter Berücksichtigung der Brandpläne und Stakeholderbedürfnisse  Analyse und Monitoring der indikationsspezifischen Marktgegebenheiten und Wettbewerber hinsichtlich der Preisgestaltung und des Marktzuganges Identifikation von Access Hürden auf nationaler Ebene, Entwicklung und Umsetzung von Strategien zur Überwindung Mitarbeit bei Konzeption, Betreuung und Auswertung wissenschaftlicher Datenerhebungen in Zusammenarbeit mit dem HEOR-Manager und der Medizin Abgeschlossenes gesundheitsökonomisches oder medizinisches / naturwissenschaftliches Studium, alternativ Studium mit relevanter Zusatzausbildung oder Weiterbildung im Bereich Gesundheitsökonomie/-politik o. ä. Langjährige Erfahrung in der pharmazeutischen Industrie oder langjährige Berufserfahrung in einer vergleichbaren Position im Gesundheitswesen, Beratung, etc. Erfahrung in der Onkologie von Vorteil Sehr gute Kenntnisse der Versorgungsstrukturen und rechtlichen Rahmenbedingungen für die Erstattung von Arzneimitteln Belastbare Kontakte zu relevanten regionalen und nationalen Stakeholdern von Vorteil Sehr gute Kenntnisse der aktuellen gesundheitspolitischen Rahmenbedingungen, Player und Netzwerke Ausgeprägtes Verständnis für die Zusammenhänge und Auswirkungen hinsichtlich des Marktzugangs sowie regionaler und nationaler Steuerungen  Einschlägige Erfahrung im Projektmanagement Gute Englisch- und MS-Office Kenntnisse Persönliche Anforderungen: Für diese Schnittstellenfunktion suchen wir eine flexible und kommunikationsstarke Persönlichkeit, die es versteht, Netzwerke aufzubauen und abteilungsübergreifend zu arbeiten. Ein eigenmotivierter und zielorientierter Arbeitsstil sind dabei ebenso unerlässlich wie die Freude am Arbeiten in cross-funktionalen Teams.  Ihre konstruktive und innovative Denkweise hilft Ihnen, die hohe Komplexität der Aufgabenstellungen zu bewältigen und die notwendigen Strategien zu erarbeiten. Sie verfügen über gute analytische Fähigkeiten und verstehen es komplizierte Zusammenhänge zielgruppengerecht darzustellen. Sie zeichnen sich durch eine hohe Kundenorientierung aus. Mobilität und die damit verbundene Bereitschaft zu Dienstreisen sind für Sie selbstverständlich. Attraktive Vergütung Work-Life-Balance Persönliches Wachstum und Entwicklung Gesundheit und Familie Was uns als Arbeitgeber ausmacht: Bei Daiichi Sankyo in Europa bieten wir Ihnen ein Arbeits­umfeld, in dem Ihre Stimme gehört wird. Grundlage von allem, was wir tun, ist ein hohes Maß an Engage­ment sowie ein klarer Fokus auf die Bedürfnisse von Patientinnen und Patienten. Wir wissen, dass unser ambitioniertes Ziel, die Lebens­qualität von Menschen weltweit zu verbessern, nur durch enge Zusammen­arbeit und die Erforschung neuer Ansätze erreicht werden kann. Deshalb motivieren wir unsere Kolleginnen und Kollegen in ganz Europa dazu, mutig zu denken, ihre Ideen einzubringen und Möglichkeiten zur Weiterent­wicklung zu nutzen. Wenn Sie ein Mitglied unserer europäischen Familie werden möchten, werden Sie in einem dynamischen Unter­nehmens arbeiten, in dem alle, unabhängig von ihrer Rolle, mit anpacken und Verant­wortung übernehmen.
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Senior Director Development Lead*

Di. 18.01.2022
Tübingen, München
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. Operating from Tuebingen, Munich and Houston, we are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. ​We are currently seeking full-time a Senior Director Development Lead* to support our global ACTallo® team and to provide strategic guidance for the development of our allogeneic cell therapy portfolio. This position can be located in Tuebingen, Munich or home based (Germany) and will report directly to the Chief Technology Officer. Your main responsibilities will include but are not limited to the following tasks: Be accountable for allogeneic cell therapy portfolio to senior management Oversee and initiate actions to optimize portfolio development, project objectives and goals, and mitigate strategical risks  Ensure overall modality development incl. pipeline strategy and interplay between programs; e.g. identify the need for project target adaptions or next-generation approaches to optimize the development potential of a program or the whole modality portfolio Facilitate the transition of early programs to late-stage Anticipate and implement (future) clinical, regulatory & market requirements into relevant deliverables on the development path Take on ownership of target product profile (TPP) and accountability for drug development plan (DDP) Guide and mentor Project Leads/ Managers, as well as scientific, translational, clinical, IP, commercial and regulatory experts, to jointly succeed in the seamless transition of candidate biologics assets from Research to, through Clinical Development, and towards Commercialization ​You hold a PhD degree in Life Sciences (preferred), or M.Sc./MD. You have proven track record of 6+ years of business experience in the biopharmaceutical area and experience in leading cross-functional teams. Significant development and/ or commercial experience as well as sound scientific understanding is a must. Hands-on knowledge with allogeneic cell therapy and significant drug development and/ or commercial exposure are desirable. To manage complex, multi-level, multi-year projects and programs with objectives & key results, you excel in engaging with a broad variety of internal and external stakeholders. You have fluent communication skills, both in English and German, and you embrace the opportunities of a growing global company.​We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g. job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
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Senior Quality Assurance Manager (m/f/d) - GMP

Di. 18.01.2022
Hallbergmoos
Pieris Pharmaceuticals (Nasdaq: PIRS) is a clinical-stage biotechnology company with operations in Germany and the United States. Pieris discovers and develops Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin® proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin® proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. It is our mission to develop life-changing therapeutic proteins for patients suffering from cancer and respiratory diseases through the innovative application of novel science and cutting-edge technologies.The Senior QA Manager – GMP, supports CMC operations as Quality representative for the clinical development projects. Conduct product release activities for master cell banks, drug substance, drug product, and the IMP for all phases of clinical development including review and approval of master batch records and executed batch records Represent the QA department on research and development project teams Manage and address deviations, investigations, corrective and preventive actions (CAPAs), change controls, and similar developments Partner with CMC Operations, Technical Development, Quality Control and Supply Chain departments within the company to assess overall product quality performance, including the identification of any product-specific quality and compliance risks, and develop mitigation plans using appropriate risk-based approaches Actively collaborate with CMOs and contract testing organizations (CTOs) to initiate, investigate, and resolve deviations and investigations prior to lot disposition Ensure compliance with CMO and CTO quality agreements Create and maintain internal and external audit plan Lead or assist auditing activities to ensure that activities for Pieris at CMOs / CTOs are conducted in accordance with protocols, regulatory and quality requirements and industry guidelines Actively lead or assist activities in the areas of Self Inspections, CAPA (Corrective and Preventive Actions) and Quality Management Reviews. Other related duties as assigned Degree in Life Sciences with relevant experience in in the pharma / biotechnology industry   Preferably more than five years QA experience in a cGMP manufacturing environment   Knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical development and operations   Fluency in spoken and written English   Strong team player with flexible and positive attitude   Strong attention to detail and critical thinking ability Pieris is a fast-growing biotechnology company with approximately 130 employees across our sites in Munich, Germany and Boston, United States. We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of our company goals. In addition, we offer each employee the opportunity to participate in a stock purchase plan as well as a stock option program that allows Pieris employees to benefit directly from the our success. Numerous social benefits such as an additional employer-financed company health insurance, free drinks etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in both of our locations round off our overall package. Creative employee events take place several times a year, as we believe that a healthy spirit of collaboration is key to our success.
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Pharmacovigilance Operations Lead (m/f/x)

Mo. 17.01.2022
München
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For our headquarter in Munich we are seeking highly qualified candidates to fill the position Pharmacovigilance Operations Lead (m/f/x) Leads the Pharmacovigilance (PV) Operations team at Daichi Sankyo Europe which focuses on individual case safety report (ICSR) handling from post-marketing. PV Operations includes all aspects of case processing in the safety database, ensuring the AE collection process (i.e. Spontaneous, Solicited, Post-Marketing Study sources), regulatory reporting requirements, vendor management for case processing and its quality and compliance. The position is closely working with the global PV operations team (US, Japan) and global case processing vendors and act as primary contact among CSPV and other functions for PV operational activities and assists in management of PV audit/inspection. Contributes to the global PV Operations strategy and decision making via the global PV operations team. The position reports to the Head of the DSE CSPV department (EU-QPPV) as well as the Global PV operations Lead. Roles and Responsibilities: ICSR handling Oversees the system for ICSR collection, processing, reconciliation and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met. This includes AE report intake, Case processing, Follow-up requests, ICSR reporting, ICSR quality control, SAE reconciliation, Partner reconciliation, Case processing vendor management, Workflow management. Ensures that all safety reports received are processed and reported according to regulatory requirements and company procedures. Supports and/or provides internal training on ICSR activities as applicable. Prepares and maintains company procedures around case management activities and assists in management of PV audit/inspections. Case processing CRO management Manages, communicates and provides trainings on ICSR activities, safety procedures and processes on a regular basis with case process service providers and oversees their quality of work. Develops and monitors case processing KPIs/metrics, and takes appropriate actions with the case process service providers to achieve continuous improvement. Study start up Oversees and works with clinical study teams, develops and maintains study- specific SAE Flow Plans/Safety Management Plans along with Product Safety Physicians to ensure all required safety information to be collected following the regulations and medical requirements. Facilitates and ensures communication with functions involved with receiving, investigating, or reporting AEs; supports cross-functional study and program teams. Develops SAE Reconciliation Plan and oversees the reconciliation process. Reviews study documents on behalf of PV Operations team (Protocol, Data Management Plan, PV Agreements/Safety Data Exchange Agreements), supports setting up electronic data capture (EDC) systems for AE collection and reporting process to the Health Authorities, Affiliates and Partners (e.g. Configuration of reporting rules in the safety database). People/Team Management Leads, manages and mentors staff and assigns responsibilities as appropriate to maximize the team outputs and provides opportunities for individual growth. Prepares individual development plans for the members within the function and supports the execution. Bachelor’s degree at minimum required; Master, PhD preferred Minimum 8 years of experience in PV with an advanced degree; 10 years of experience with bachelor’s degree Leadership skills, Positive attitude Strong PV regulation knowledge Knowledge of international and European PV laws Experience in case management Strong communication skills Fluent business English (oral and written) Relocation to Munich preferred Competitive Pay Work-Life-Balance Growth and Development Health and Family Working at Daiichi Sankyo: At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
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Senior Manager Regulatory Affairs Oncology (m/f/x)

Sa. 15.01.2022
München
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For our Headquarter in Munich we are seeking two highly qualified candidates to fill the position: Senior Manager Regulatory Affairs Oncology (m/f/x) To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary team, providing expertise on regulatory matters. Represent Regulatory Affairs in external interactions (e.g. authorities, affiliates, partners, CROs) providing expertise on regulatory strategy to achieve regional and global goals. Role and Responsibilities European regulatory strategy support for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management. European Regulatory Affairs representation on global development teams providing regulatory guidance and strategy and supporting EU MAA submissions Act as regulatory contact person for authorities for assigned projects Participate in assigned non-project tasks and process improvements Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus Minimum of 8 years of experience in the pharmaceutical industry and minimum of 5 years of experience in global regulatory affairs with emphasis on late stage drug development and marketing authorization applications in Europe, experience with clinical trials, orphan drugs and pediatric clinical development Experience of working in global environment as well as with National Health Agencies and EMA Proven ability to plan, coordinate and lead activities simultaneously on multiple project Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner Solution and detail-oriented; well organised and self-motivated Excellent written and oral communication skills in English, second language preferred Competitive Pay Work-Life-Balance Growth and Development Health and Family Working at Daiichi Sankyo: At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
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Executive Quality Advisor (m/w/d) - Life Science Quality Management

Fr. 14.01.2022
Düsseldorf, Berlin, Frankfurt am Main, München, Stuttgart
Making an impact that matters. Unser Anspruch ist, jeden Tag das zu tun, was wirklich zählt. Mit unserem breiten Leistungsspektrum – von Audit & Assurance, Risk Advisory über Tax & Legal bis Financial Advisory und Consulting – unterstützen wir Kunden auf einzigartige Weise. Wir setzen neue Maßstäbe, liefern innovative Denkansätze und ermöglichen nachhaltiges Wachstum. Wir fördern unsere hochqualifizierten Mitarbeitenden mit ihren verschiedensten Talenten, sodass sie mit uns mehr erreichen. Im Business Risk Advisory unterstützen wir unsere Kund:innen bei der Identifizierung und Vorbeugung potenzieller Risiken in allen Geschäftsbereichen. Dabei betrachten wir finanzielle, technologische und geschäftsrelevante Risiken, um den Unternehmenserfolg langfristig zu sichern. Im Team von Regulatory & Legal Support entwickeln Sie für unsere Kund:innen individuelle Lösungsansätze zur Bewältigung aktueller Herausforderungen, die aus der Digitalisierung und Entwicklung sowie Implementierung von Risikomodellen branchenübergreifend resultieren. Dabei beraten Sie zu Themen der optimalen organisatorischen und prozessualen Ausgestaltung der Geschäftsmodelle und der Compliance von Unternehmen in regulierten Branchen.   Für unsere Teams an den Standorten Düsseldorf, Berlin, Frankfurt (Main), München und Stuttgart suchen wir engagierte Verstärkung. Die Digitalisierung in einem regulierten Umfeld wie die Life Science Industrie wird nur ganzheitlich gelingen, wenn wir das Herzstück, das Qualität Management System, zu einem digitalen intelligenten Informationsmanagement transformieren. Dieser Herausforderung nehmen wir uns an. Als Kernmitglied des cross-disziplinären Entwicklungsteams verantworten Sie die regulatorische Sicherstellung digitaler Assets und Managed Services für ein digitales Qualitätsmanagementsystem Sie leiten die regulatorische Betrachtung/Impact Analyse/Risikobewertung neuartiger digitaler Lösungen und Haftungsfragen und leiten den Austausch mit Behörden Sie beraten das Team über den aktuellen Stand der regulatorischen Anforderungen mit einem Fokus auf Data Integrity und Computerized System Validation Als Quality Advisor in den Umsetzungsprojekten verantworten Sie die regulatorische Beratung in der Anwendung innovativer Technologien und leiten Quality Maturity/Performance Assessments Mit Ihrer regulatorischen Expertise und Ihrem Industrie Wissen tragen Sie maßgeblich zu einer erfolgreichen Go-to-Market Strategie bei Als „Ambassador“ sind Sie aktive:r Netzwerker:in in der Life Science Industrie (inklusiver entsprechender Publikationen/Präsentationen) und fungieren als Meinungsbilder:in und aktive:r Gestalter:in im Austausch mit Expertengremien und Behörden Sie überschauen die weltweiten regulatorischen Trends und treiben aktiv den Deloitte internen Wissensaustausch voran Erfolgreich abgeschlossenes Hochschulstudium (Master Degree) der Fachrichtung Pharmazie, Medizin, Ingenieurswissenschaften oder vergleichbarer Naturwissenschaften. Idealerweise verfügen Sie ergänzend über eine Business Zertifizierung (MBA) Exzellentes, breites regulatorisches Wissen mit Fokus auf Data Integrity, Computerized System Validation in der digitalen Anwendung Mindestens 15 Jahre Berufserfahrung in Senior Quality Positionen in der Life Science/Healthcare Industrie oder Behörden, davon mehrjährige Erfahrung in der Produktion in QA/QC, Quality Management System, und/oder Audit Management Exzellentes analytisches Denkvermögen, sowie ausgeprägte, cross-disziplinäre Teamorientierung Sehr gute Kommunikationsfähigkeiten, um komplexe Zusammenhänge kundenspezifisch, präzise und überzeugend darzustellen Sehr hohe Verhandlungskompetenz (auch mit Behörden) und ausgeprägte Lösungsorientierung Gute MS-Office- Anwender-Kenntnisse Sehr gute Englisch- und Deutschkenntnisse Flexibilität und Reisebereitschaft Neben einer angenehmen, kollegialen Atmosphäre bieten wir Ihnen ein chancenreiches, internationales Arbeitsumfeld. Bei uns gelten flache Hierarchien und ein Prinzip der offenen Tür. Wir bieten eine Vielzahl von Entwicklungsprogrammen, insbesondere für das Senior Management. Hierdurch unterstützen wir aktiv Ihre berufliche und persönliche Entwicklung. Ein weiterer Pluspunkt: Ihre leitende Mitarbeit an einem neuartigen Quality Management System für die Life Science Industrie, und die damit verbundene Reputation, stellen eine einzigartige Karrierechance für Sie dar.
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Regulatory Affairs Coordinator (m/f/d)

Fr. 14.01.2022
München
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. We are looking for a Regulatory Affairs Coordinator (m/f/d) to join our International Regulatory Affairs team in our new office in Munich. This is a permanent role reporting into our Director Regulatory Affairs. Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Administrative office routines: Assists in compilation and submission of regulatory documents to the local regulatory authorities and – as applicable - to the European Medicines Agency (EMA); Assist in department administrative tasks, online regulatory database searches and managing the departmental intranet presence; Assist in managing incoming parallel trade notifications Compliance: Build and maintain standard Regulatory Official Files and archiving of regulatory documentation according to local procedures; ensure that regulatory databases and systems are kept updated and complete; participate in implementation of updated regulatory documentation and processes according to Agency requirements and in-house guidance Editing and labelling: assist in preparation, translation and proof-reading/quality-check of product information documents Artwork development: ensure artwork (i.e. packaging components templates) is developed in time and according to local procedures; develop Packaging Material in cooperation with colleagues from other departments; proofreading packaging components and maintaining updated f Master of Science, a scientific or business Traineeship or equivalent education Basic medical and scientific understanding and knowledge Sound skills and usage of modern electronic collaboration platforms, online applications, databases and document management systems Additional education or qualification regarding business or financial administration as well as communications or media creation are a plus Basic skills and knowledge of local regulatory framework are a plus Notable problem solver and ability to work in teams Commitment & dedication to quality and the ability to handle multiple priorities simultaneously Fluent in German and English – spoken and written Attractive salary package Generous Pension plan 30 holidays Training and development opportunities Flexible work model with possibility to partially work from home We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 
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Senior Manager CMC Regulatory Affairs (m/f/x)

Fr. 14.01.2022
München
Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world”. In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society”. For our headquarter in Munich we are seeking highly qualified candidates to fill the position: Senior Manager CMC Regulatory Affairs (m/f/x) The Senior Manager Regulatory Affairs CMC will provide European regulatory CMC guidance and strategy for assigned products and will represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working teams, authorities interactions (Scientific Advice), CMOs). The function will support or lead the preparation of regulatory CMC documents during development and life cycle management in a manner that is scientifically sound, commercially viable and in accordance with regulatory CMC standards. He/She may act as a specialist for biological products in the EU regulatory CMC field. The function communicates EU and international regulatory requirements to authoring teams, develop the EU regulatory strategies and review dossiers and technical documents. The function and the team collaborates companywide within the global RACMC department and technical functions. The function is proactively influencing the internal, but also external regulatory affairs environment. Roles and responsibilities: Working in regulatory teams to conduct preparation of M2 and M3 CTD documents for EU MAAs and IMPDs filings of new drugs, incl. Quality Overall Summary (QOS) Represent EU RACMC function in global RACMC and CMC development teams and provide CMC regulatory guidance and strategy Review CMC documents, develop regulatory strategies, provide risk assessments Support the preparation and execution of Health Authority meetings Interpret, develop strategy and lead response preparation on Health Authorities information requests Keep close collaboration with global RACMC colleagues and technical experts, across all regions Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders Participate or lead assigned non-project tasks and process improvements Ensure maintenance of the regulatory compliance Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus Minimum of 5 years of experience in the pharmaceutical industry Minimum of 3 years of experience in global regulatory affairs CMC with emphasis on late stage CMC drug development and marketing authorization applications in Europe; experience in the development of biologics preferred Proven ability to plan, coordinate and lead activities simultaneously on multiple projects Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation Experience of working in global environment in interdisciplinary teams Experience of working in or leading interdisciplinary teams Solution and detail-oriented; well organised and self-motivated Excellent written and oral communication skills in English, German as a second language preferred Strong working knowledge of Microsoft Office We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.
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PTA / Pharmazeutisch-technische/r Assistent/in (m/w/d) bis zu 22€ Stundenlohn

Do. 13.01.2022
Heidelberg, Stuttgart, München, Nürnberg, Mainz, Frankfurt am Main, Karlsruhe (Baden), Augsburg, Ulm (Donau), Münster, Westfalen
Astriol pharmaceutics ist die Lösung, wenn es um Fachpersonal in den Bereichen Pharmazie und Apothekenwesen geht. Wir schaffen leistungsstarke Verbindungen zwischen Apotheken und Fachpersonal. Unser Antrieb ist stets die größtmögliche Zufriedenheit für beide Seiten. Mit uns an Deiner Seite stehen Dir deutschlandweit vielseitige Wege zu exklusiven Einsätzen offen. Profitiere von unserer langjährigen Erfahrung und tiefgründigen Marktkenntnis im Rahmen unserer Spezialisierung. Arbeite in starken Teams und lerne Apotheken, Krankenhäuser, öffentliche Träger sowie Pharmaunternehmen jeglicher Größen kennen. Wir wissen was wir machen und sind genau deshalb so gut, indem was wir tun. Astriol pharamceutics gehört zur erfahrenen und wachstumsstarken Astriol Gruppe. Du möchtest in einen abwechslungsreichen Alltag mit facettenreichen Aufgaben starten? Dann bist Du bei Astriol pharmaceutics genau richtig. Wir bieten Dir die Chance, Deine Expertise rasch auszubauen, indem Du an Aufgaben wächst und Herausforderungen meisterst. Gestalte die Zukunft am Puls der Zeit und genieße sowohl die Freiheit selbstbestimmt zu arbeiten, als auch von allen Sicherheiten eines Angestellten zu profitieren. Durch uns erfährst Du die Wertschätzung, die gute Arbeit verdient. Jetzt bewerben und schon bald zu den Besten gehören. Von den Besten - mit den Besten - für die Besten.   Wir suchen Dich zum nächstmöglichen Zeitpunkt als PTA / Pharmazeutisch-technische/r Assistent/in (m/w/d) Kundenberatung und -betreuung Bearbeitung, Kontrolle und Beratung der Rezeptbestellungen Kunden und Patienten über Arzneimittel und Medizinprodukte informieren Verkauf von Arzneimitteln und Medizinprodukten Bearbeitungen von Bestellungen - persönlich, telefonisch oder per Mail Arzneimittelherstellung nach Rezept Meldungen der Arzneimittelrisiken aus den Apotheken bearbeiten und dokumentieren Verwaltungstätigkeiten und Überwachung der Warenbestände Du besitzt eine abgeschlossene Ausbildung zum pharmazeutisch-technischen Assistenten (m/w/d) Gutes Fachwissen und EDV-Kenntnisse Zertifikat zum Anmessen von Kompressionsstrümpfen von Vorteil Du bist kommunikativ, kontaktfreudig und hast Spaß an persönlichen Beratungen Zuverlässige, kundenorientierte und teamfähige Arbeitseinstellung Engagierte, strukturierte und selbstständige Vorgehensweise Du verfügst über sehr gute Deutsch- sowie Englischkenntnisse in Wort und Schrift Du hast die Wahl zwischen zwei verschiedenen modern working Modellen Work-Life-Balance unbefristeter Arbeitsvertrag 35-Stunden-Woche Vollzeit Dienstwagen/Fahrgeld Urlaubs u. Weihnachtsgeld Betriebliche Altersvorsorge Betriebliche Krankenversicherung Fitnessstudio Zuschläge Fort- und Weiterbildungen zusätzlicher Familienurlaub mgl. Kitazuschuss mgl. Sabbatical mgl.   Work & Travel unbefristeter Arbeitsvertrag 40-Stunden-Woche Vollzeit Dienstwagen / Fahrgeld Urlaubsgeld - Weihnachtsgeld Betriebliche Altersvorsorge Betriebliche Krankenversicherung Verpflegungsmehraufwand (VMA) Fitnessstudio Zuschläge Fort- und Weiterbildungen
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