152 Jobs für Drug Regulatory Manager
Stellenangebote Drug Regulatory Manager Jobs
Job vor 3 Tagen bei Stellen-Online gefunden
PARI Pharma GmbH
• 82319, Starnberg
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit ein [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten [. .. ] Studien, Therapie-Guidelines und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil:Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
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Job am 16.01.2026 bei Mindmatch.ai gefunden
PARI Pharma GmbH
Medical Affairs Manager (m/w/d)
• Starnberg, BY
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit ein [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten [. .. ] Therapie-Guidelines und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
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Job am 17.01.2026 bei jobanzeigen.de gefunden
PARI Pharma GmbH
• starnberg, Deutschland
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit ein [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten [. .. ] Therapie-Guidelines und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil: Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
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Job vor 4 Tagen bei Jooble gefunden
Abb Vie
Product Manager (m/w/d) in Vollzeit Head of Product (m/w/d)
• Ludwigshafen am Rhein
Führungs-/ Leitungspositionen
Work-Life-Balance
[. .. ] about improving global health care? In a challenging work environment that offers opportunities of developing and increasing your own skills? Moving mountains together as Principal Research Scientist [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] I/ II/ Biologics Drug Product Lead (R D) (all genders) (full-time, permanent) The scientific background of the incumbent should include formulation, manufacturing process development, container closure systems, quality risk management and analytical development. Solid experience with various molecule types, working in a global team and strategic as well as scientific thinking is a [. .. ] (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality Assurance, CMC Regulatory Affairs, parental Product Development Science Technology (Operations) and external partners You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase [. .. ]
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Job vor 4 Tagen bei Jooble gefunden
Abb Vie
• Ludwigshafen am Rhein
Work-Life-Balance
[. .. ] about improving global health care? In a challenging work environment that offers opportunities of developing and increasing your own skills? Moving mountains together as Principal Research Scientist [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] I/ II/ Biologics Drug Product Lead (R D) (all genders) (full-time, permanent) The scientific background of the incumbent should include formulation, manufacturing process development, container closure systems, quality risk management and analytical development. Solid experience with various molecule types, working in a global team and strategic as well as scientific thinking is a [. .. ] (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality Assurance, CMC Regulatory Affairs, parental Product Development Science Technology (Operations) and external partners You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase [. .. ]
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Job vor 4 Tagen bei Jooble gefunden
Abb Vie
Product Manager (m/w/d) - Vollzeit
• Ludwigshafen am Rhein
Work-Life-Balance
[. .. ] about improving global health care? In a challenging work environment that offers opportunities of developing and increasing your own skills? Moving mountains together as Principal Research Scientist [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] I/ II/ Biologics Drug Product Lead (R D) (all genders) (full-time, permanent) The scientific background of the incumbent should include formulation, manufacturing process development, container closure systems, quality risk management and analytical development. Solid experience with various molecule types, working in a global team and strategic as well as scientific thinking is a [. .. ] (Product Development Strategy Team leader) for all Drug Product Development topics and will work closely with cross-functional subject matter experts from Discovery, analytical, and device development, Quality Assurance, CMC Regulatory Affairs, parental Product Development Science Technology (Operations) and external partners You represent Biologics Drug Product Development Germany as single point of contact in global Product Development Strategy Teams and are responsible for the formulation, manufacturing process and container closure system development of early-stage biological assets up to clinical phase [. .. ]
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Job vor 10 Tagen bei Jooble gefunden
Abb Vie Deutschland GmbH Co. KG
• Ludwigshafen am Rhein
[. .. ] in the development and life cycle for primary packaging components and collaboration with manufacturing, quality, procurement, development, device teams and external partners to ensure successful development and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] commercialization of the drug product. In your role as technical expert for CCS you will work collaboratively with experts in global multi-functional teams and serve as Technical Lead on your own projects and contribute CCS insights into multiple other projects from early development through to product launch, technical commercial support and life cycle [. .. ] Ph D degree (and 6+ years) in Parenteral manufacturing, Parenteral process development, Container closure and combination product development, Product Quality, Analytical, Material Sciences, or related fields Profound knowledge of quality and regulatory requirements for container closure systems for parenteral pharmaceutical and biopharmaceutical products, primary packaging materials and drug/ device combinations products Strong leadership and communication skills, demonstrated through the successful establishment and management of cross-functional teams in a manufacturing setting with a diverse work environment where you can have a real [. .. ]
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Job am 18.01.2026 bei Jooble gefunden
Gilead Sciences
Sr Manager Market Access (m/f/d) Biotstatistics/ Epidemiology-Cell Therapy Oncology
• München
[. .. ] in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Job Description Sr Manager Market Access (m/f/d) Biotstatistics/ Epidemiology-Cell Therapy Oncology Company Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/ AIDS, liver diseases, cancer, inflammation, and serious respiratory conditions. The Position M arket Access is a highly strategic function with broad cross-functional interaction across the [. .. ] needs, with a focus on AMNOG Ensuring pricing analysis and modelling, support of price databases Design, conduction and publication of HEOR studies, including RWD Collaboration with local Market Access, Medical, Regulatory, Government and Public Affairs colleagues, Global HEOR and Value Access colleagues. Knowledge, Experience and Skills Masters degree in Biostatistics and profound knowledge in Market Access 3+ years of experience in Biotech, Pharma or healthcare organizations with a focus on Market Access Excellent understanding and application of statistical methods defined by [. .. ]
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Job am 16.01.2026 bei Jooble gefunden
Abb Vie
• Wiesbaden
[. .. ] to ensure that evidence generated will support successful Joint Clinical Assessments (JCA) and HTA outcomealong with PRA negotiations. The International HTA Strategy team wasestablishedtorealize the full value [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of our assets by strategically informing drug development, evidencegenerationand HTA submissions, aligned with HTA/ payer needs. The primary goals of the function are to ensure HTA evidence requirements are considered early in the development of Abbvie assets and a robust and aligned HTA strategyincluding EUHT Aacross the organizationin order toensure the successful launch of Abbvie assets. The International HTA Strategy teamoversees EU HTA Regulation implementation for Abb Vie and leads JSC and JCA strategy development and execution. Purpose Asa JCA Dossier Manager, you will leadend-to-end JC Adossierprocess supporting the strategy development and execution of JC Adossier. You willprovideexpertisein EUHT Aregulationsensuring that all requirementsare met. Serves as an EU HT Adossierexpert for the JCA dossier team. You will ensure the JCA cross-functional teams successfully deliverhigh quality executionof all JCA procedural stepswithin scope, on time, and within budget. You will ensure that projectobjectivesare achieved while adhering to quality and regulatory standards. You will serve as a liaison to HTA external authorities. You will serve as the JCA dossierexpertfor all Therapeutics Areasandall European countries. As EU HTA introduces new requirements and expectations, you will help shape internal operational processes, embed learnings, and build organizational capability in this evolving environment. Keyresponsibilities: Lead the [. .. ]
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Job am 16.01.2026 bei JobMESH gefunden
PARI Pharma GmbH
Medical Affairs Manager (m/w/d)
• Bayern 82319 Starnberg
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit ein [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten [. .. ] Studien, Therapie-Guidelines und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil:Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
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Job am 15.01.2026 bei Jooble gefunden
TFS Health Science
• Hamburg
[. .. ] Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] The Local Study Manager is responsible for the planning, execution, and oversight of clinical studies at the country level, ensuring delivery of high-quality data within timelines, budget, and regulatory compliance. As part of our SRS team, you will be dedicated to one sponsor, a global pharmaceutical/ biotech company that is an industry leader in Oncology drug development. Key Responsibilities: Lead and coordinate the execution of one or more oncology clinical studies at a local/ country level. Ensure compliance with ICH-GCP, regulatory requirements, and sponsor/ CRO SOPs. Oversee site feasibility, selection, initiation, monitoring, and close-out activities. Act as the main point of contact for investigational [. .. ]
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Job am 14.01.2026 bei Jooble gefunden
Coriolis Pharma Research GmbH
Quality Manager Quality Management (m/w/d)
• Planegg
[. .. ] compliance and excellence across qualification and validation activities. In this role, you will help ensure that all qualification and validation tasks are completed efficiently, effectively, and in [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] full compliance with regulatory standards. Release equipment for GMP use after successful completion of qualification projects in collaboration with QA. Support handling of (equipment-related) changes, deviations, CAPAs, SST failures, risk assessments, and OOS cases. Analytical Method Validation Lifecycle Management: Provide validation support for technology transfers and process changes. Collaborate with analytical teams during [. .. ] to shape your development possibilities here at Coriolis. Coriolis Pharma is a global contract research and development organization (CRDO) and a premier partner for the development of liquid and lyophilized drug products, analytical services, and manufacturing services across a vast array of therapeutic modalities, including biologics, gene and cell therapies and vaccines. Our company culture is based on diversity, teamwork and open and appreciative communication. An additional project management and business development team in the United States enables our US clients [. .. ]
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Job am 14.01.2026 bei Jooble gefunden
Coriolis Pharma Research GmbH
• Planegg
[. .. ] validation lifecycle, and ensure proper documentation and traceability. In this role, you will help ensure that all qualification and validation tasks are completed efficiently, effectively, and in [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] full compliance with regulatory standards. Join Coriolis Pharma a science-driven organization committed to quality and innovation Your Responsibility Qualification Validation Activities: Compile, review, and approve instrument qualification documentation. Release equipment for GMP use after successful completion of qualification projects in collaboration with QA. Compile, review, and approve risk assessments related to equipment qualification. [. .. ] 0 Fraunhoferstraße 18 b, 82152 Martinsried About us Coriolis Pharma is a global contract research and development organization (CRDO) and a premier partner for the development of liquid and lyophilized drug products, analytical services, and manufacturing services across a vast array of therapeutic modalities, including biologics, gene and cell therapies and vaccines. Our scientists design and execute platform and custom services to accelerate and derisk our clients programs right from the start and throughout the entire product lifecycle. Our company culture [. .. ]
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Job am 14.01.2026 bei Jooble gefunden
NVision Imaging Technologies
Senior Test Verification Engineer (m/f/d)
• Ulm
Work-Life-Balance
[. .. ] documented, analyzed, and translated into actionable outcomes and ensure timely communication of critical findings. Work closely with analytical chemistry and pharmaceutical experts to interpret the impact of [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] process variables on drug product purity and sterility. Product Verification Strategy Drive the development of a formal test-and verification process and define templates and standards Formally derive test specifications from product requirements Own the verification and validation activities with our external development partners, ensuring full alignment with regulatory requirements. Your profile Degree in Mechanical, Mechatronics or Medical Engineering or a related technical field. 4+ years of professional experience in testing or systems engineering within an interdisciplinary R D environment. Strong knowledge of testing methodologies, lab procedures, and hardware and software system integration. Extensive hands-on test lab experience, [. .. ] Permanent employment contract, providing stability and long-term career growth opportunities 30 vacation days and excellent work-life balance contact information Any questions? Please contact: Sandra Schärli Senior Talent Acquisition Manager mail: Please note that, for data privacy reasons, we ll not review applications or CVs sent via email. Unsolicited applications can be submitted here. About us NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are just leaving stealth [. .. ]
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Job am 14.01.2026 bei Jooble gefunden
Denk Pharma GmbH Co. KG
• München
Abgeschlossenes Studium Abgeschlossene Ausbildung
Flexible Arbeitszeiten Betriebliche Altersvorsorge
[. .. ] erreichen Das solltest du mitbringen: Ein erfolgreich abgeschlossenes Pharmazie-/ Medizinstudium oder ein naturwissenschaftliches Studium oder eine erfolgreich abgeschlossene Ausbildung aus dem medizinisch-technischem oder naturwissenschaftlichem Bereich Erste Berufserfahrung [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] im Bereich Drug Regulatory Affairs, idealerweise im globalen Umfeld Sehr gute Englisch- und Deutschkenntnisse in Wort und Schrift Kommunikationsstärke und hoher Teamspirit sowie Freude daran, mit unterschiedlichen Kulturen zusammenzuarbeiten Eine sehr strukturierte, eigenständige sowie konzeptionelle Denk- und Arbeitsweise Ein ausgeprägtes Verantwortungsbewusstsein, um Aufgaben mit einem ganzheitlichen Ansatz zu verfolgen und erfolgreich bis zum Abschluss [. .. ]
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Job am 14.01.2026 bei Jooble gefunden
Alexion Pharmaceuticals
Clinical Research Associate
• München
[. .. ] an active participant in the local study team (s) . The CRA works in close collaboration with local team members (Project Management Clinical Operations (PMCO) , Study [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Clinical Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner on a site level. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to [. .. ] with ICH-GCP, Alexion SOPs and local requirements. Supporting/ participating in regular QC checks of the e TMF In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/ documents to EC/ IRB and to Regulatory Authorities for start-up and for the duration of the study. Contributing to the nomination and selection of potential investigators and assisting with feasibility [. .. ] international guidelines ICH-GCP, basic knowledge of GMP/ GDP. Excellent knowledge of relevant local regulations. Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas. Good understanding of the drug development process. Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management. Excellent attention to details. Excellent written and verbal communication skills. Excellent collaboration and interpersonal skills. Good negotiation skills. Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70 [. .. ]
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Job am 14.01.2026 bei Jooble gefunden
Coriolis Pharma Research GmbH
• Planegg
[. .. ] compliance and excellence across qualification and validation activities. In this role, you will help ensure that all qualification and validation tasks are completed efficiently, effectively, and in [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] full compliance with regulatory standards. Release equipment for GMP use after successful completion of qualification projects in collaboration with QA. Support handling of (equipment-related) changes, deviations, CAPAs, SST failures, risk assessments, and OOS cases. Analytical Method Validation Lifecycle Management: Provide validation support for technology transfers and process changes. Collaborate with analytical teams during [. .. ] to shape your development possibilities here at Coriolis. Coriolis Pharma is a global contract research and development organization (CRDO) and a premier partner for the development of liquid and lyophilized drug products, analytical services, and manufacturing services across a vast array of therapeutic modalities, including biologics, gene and cell therapies and vaccines. Our company culture is based on diversity, teamwork and open and appreciative communication. An additional project management and business development team in the United States enables our US clients [. .. ]
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Job am 14.01.2026 bei Jooble gefunden
Thermo Fisher Scientific
Local Clinical Trial Manager-FSP, Germany-6 month FTC (m/f/d)
• Homeoffice
[. .. ] protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] members or line manager. Works to ensure that all clinical deliverables meet the customer s time/ quality/ cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs. A day in the Life: Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc. ) , vendor staff, and external clinical site staff involved in study preparation and delivery providing both matrix leadership and project management of study activities within the country (ies) . Serves as the operational point-of-contact between the central study team and within-country [. .. ] environment, processes, and systems. Demonstrates excellent leadership skills, promoting motivation and high-quality performance of others to accomplish individual, team, and organizational objectives. Demonstrates an excellent understanding of clinical study, drug development, sample management, and other associated processes and quality requirements. Has a strong project management approach and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners. Proficient in acting as the organization s spokesperson to external physician investigators and other external clinical [. .. ]
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Job am 17.01.2026 bei Neuvoo.com gefunden
PARI Pharma GmbH
Medical Affairs Manager (m/w/d)
• Bavaria Starnberg
Abgeschlossenes Studium
Flexible Arbeitszeiten
[. .. ] Angehörige dabei, ihr Leben zu erleichtern. Werden Sie Teil unserer Mission und gestalten Sie mit uns die Zukunft Bringen Sie Ihre Expertise am Standort Starnberg mit ein [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] als Medical Affairs Manager (m/w/d) in Vollzeit (Schwerpunkt: Klinische Bewertung Medizinprodukte) Als Medical Affairs Manager (m/w/d) übernehmen Sie eine zentrale Rolle bei der medizinisch-wissenschaftlichen Bewertung und Begleitung unserer Medizinprodukte insbesondere solcher, mit denen Arzneimittel vernebelt werden. Sie gestalten klinische Bewertungen eigenverantwortlich und stellen deren regulatorische Konformität über den gesamten [. .. ] Therapie-Guidelines und gesundheitspolitischer Entwicklungen Fachlicher Austausch mit externen Dienstleistern, ggf. Prüfstellen und weiteren Partnern Ihr Profil Abgeschlossenes Studium der Medizin, Pharmazie oder Naturwissenschaften idealerweise ergänzt durch einen Master of Drug and Regulatory Affairs Mehrjährige praktische Erfahrung in der Erstellung klinischer Bewertungen für Medizinprodukte, bevorzugt im Umfeld von inhalativen/ respiratorischen Systemen Sehr gute Kenntnisse der MDR sowie der regulatorischen Anforderungen an CERs Erfahrung aus einem Dienstleistungsumfeld (z. B. Consulting, CRO, Regulatory Service Provider) von Vorteil Routine im Arbeiten in komplexen Projektstrukturen Erfahrung in [. .. ]
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Job vor 8 Tagen bei Jooble gefunden
Regeneron
Country Medical Director (f/m/d) , Germany
• München
Führungs-/ Leitungspositionen
[. .. ] strengthen Regenerons scientific presence in Germany. A Typical Day Might Include The Following: Serve as the key Regeneron medical representative in Germany for internal stakeholders (Medical Affairs, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Clinical Development, Operations, Regulatory, Commercial) and external stakeholders (medical societies, academic institutions, key opinion leaders) . Represent Medical Affairs in crossfunctional internal meetings, partnering closely with global Therapeutic Area Medical Directors and Medical Affairs teams such as HEOR, Medical Education and Medical Information to optimize strategic and tactical planning. Provide medical leadership to clinical [. .. ] the pharmaceutical/ biotech industry, primarily in Medical Affairs leadership roles. Demonstrated leadership experience managing officebased and fieldbased Medical Affairs teams. Strong knowledge of the German healthcare ecosystem, regulatory landscape, and drug development processes. Proven ability to work effectively in a matrixed, crossfunctional environment and drive strategic medical plans. Outstanding medical communication skills, with the ability to deliver succinct, actionable insights. A track record of building and sustaining relationships with internal stakeholders and external experts. High scientific integrity, reliability, and the ability [. .. ] most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof) , sex, nationality, national or ethnic origin, civil [. .. ]
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Job vor 8 Tagen bei Jooble gefunden
Regeneron
Medical Manager/in (m/w/d)
• München
[. .. ] partner with global and international teams, and strengthen Regenerons scientific presence in Germany. Serve as the key Regeneron medical representative in Germany for internal stakeholders (Medical Affairs, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Clinical Development, Operations, Regulatory, Commercial) and external stakeholders (medical societies, academic institutions, key opinion leaders) . Represent Medical Affairs in crossfunctional internal meetings, partnering closely with global Therapeutic Area Medical Directors and Medical Affairs teams such as HEOR, Medical Education and Medical Information to optimize strategic and tactical planning. Provide medical leadership to clinical [. .. ] the pharmaceutical/ biotech industry, primarily in Medical Affairs leadership roles. Demonstrated leadership experience managing officebased and fieldbased Medical Affairs teams. Strong knowledge of the German healthcare ecosystem, regulatory landscape, and drug development processes. Proven ability to work effectively in a matrixed, crossfunctional environment and drive strategic medical plans. Outstanding medical communication skills, with the ability to deliver succinct, actionable insights. Strong strategic thinking, stakeholder management, and the ability to simplify complex medical concepts. Fluency in English and German. Significant leadership experience [. .. ]
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Job vor 8 Tagen bei Jooble gefunden
Regeneron
Clinical Medical Manager (m/w/d)
• München
[. .. ] partner with global and international teams, and strengthen Regenerons scientific presence in Germany. Serve as the key Regeneron medical representative in Germany for internal stakeholders (Medical Affairs, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Clinical Development, Operations, Regulatory, Commercial) and external stakeholders (medical societies, academic institutions, key opinion leaders) . Represent Medical Affairs in crossfunctional internal meetings, partnering closely with global Therapeutic Area Medical Directors and Medical Affairs teams such as HEOR, Medical Education and Medical Information to optimize strategic and tactical planning. Provide medical leadership to clinical [. .. ] the pharmaceutical/ biotech industry, primarily in Medical Affairs leadership roles. Demonstrated leadership experience managing officebased and fieldbased Medical Affairs teams. Strong knowledge of the German healthcare ecosystem, regulatory landscape, and drug development processes. Proven ability to work effectively in a matrixed, crossfunctional environment and drive strategic medical plans. Outstanding medical communication skills, with the ability to deliver succinct, actionable insights. Strong strategic thinking, stakeholder management, and the ability to simplify complex medical concepts. Fluency in English and German. Significant leadership experience [. .. ]
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Job vor 8 Tagen bei Jooble gefunden
Regeneron
Medical Manager (m/w/)
• München
[. .. ] partner with global and international teams, and strengthen Regenerons scientific presence in Germany. Serve as the key Regeneron medical representative in Germany for internal stakeholders (Medical Affairs, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Clinical Development, Operations, Regulatory, Commercial) and external stakeholders (medical societies, academic institutions, key opinion leaders) . Represent Medical Affairs in crossfunctional internal meetings, partnering closely with global Therapeutic Area Medical Directors and Medical Affairs teams such as HEOR, Medical Education and Medical Information to optimize strategic and tactical planning. Provide medical leadership to clinical [. .. ] the pharmaceutical/ biotech industry, primarily in Medical Affairs leadership roles. Demonstrated leadership experience managing officebased and fieldbased Medical Affairs teams. Strong knowledge of the German healthcare ecosystem, regulatory landscape, and drug development processes. Proven ability to work effectively in a matrixed, crossfunctional environment and drive strategic medical plans. Outstanding medical communication skills, with the ability to deliver succinct, actionable insights. Strong strategic thinking, stakeholder management, and the ability to simplify complex medical concepts. Fluency in English and German. Significant leadership experience [. .. ]
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Job vor 10 Tagen bei Jooble gefunden
Abb Vie
Strategic Clinical Planning Manager (m/w/d)
• Wiesbaden
[. .. ] to ensure that evidence generated will support successful Joint Clinical Assessments (JCA) and HTA outcomealong with PRA negotiations. The International HTA Strategy team wasestablishedtorealize the full value [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of our assets by strategically informing drug development, evidencegenerationand HTA submissions, aligned with HTA/ payer needs. The International HTA Strategy teamoversees EU HTA Regulation implementation for Abb Vie and leads JSC and JCA strategy development and execution. Asa JCA Dossier Manager, you will leadend-to-end JC Adossierprocess supporting the strategy development and execution of JC Adossier. You will ensure that projectobjectivesare achieved while adhering to quality and regulatory standards. Responsible for effective communicationof JCA Dossier team includingliaison with EUHTA Steering Committee, VAT, Affiliatesand senior management. Responsible for the development of project plans, timelines, budgetsandvendor evaluationwhile holdingall stakeholders accountable to meet timelines and conduct activitieseffectively. Actsas advisorto the JCA core team and coordinate JCA dossiercross-functional teams, including Access Lead, [. .. ]
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Job am 24.01.2026 bei Jooble gefunden
Abb Vie
Technical Manager m/V
• Ludwigshafen am Rhein
Work-Life-Balance
[. .. ] in the development and life cycle for primary packaging components and collaboration with manufacturing, quality, procurement, development, device teams and external partners to ensure successful development and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] commercialization of the drug product. In your role as technical expert for CCS you will work collaboratively with experts in global multi-functional teams and serve as Technical Lead on your own projects and contribute CCS insights into multiple other projects from early development through to product launch, technical commercial support and life cycle [. .. ] Ph D degree (and 6+ years) in Parenteral manufacturing, Parenteral process development, Container closure and combination product development, Product Quality, Analytical, Material Sciences, or related fields Profound knowledge of quality and regulatory requirements for container closure systems for parenteral pharmaceutical and biopharmaceutical products, primary packaging materials and drug/ device combinations products Strong leadership and communication skills, demonstrated through the successful establishment and management of cross-functional teams in a manufacturing setting with a diverse work environment where you can have a real [. .. ]
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Häufig gestellte Fragen
Wieviel verdient man als Drug Regulatory Manager pro Jahr?
Als Drug Regulatory Manager verdient man zwischen EUR 60.000,- bis EUR 90.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Drug Regulatory Manager Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 152 offene Stellenanzeigen für Drug Regulatory Manager Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Manager Jobs?
Aktuell suchen 33 Unternehmen nach Bewerbern für Drug Regulatory Manager Jobs.
Welche Unternehmen suchen nach Bewerbern für Drug Regulatory Manager Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Drug Regulatory Manager Stellenangebote:
- PARI Pharma GmbH (8 Jobs)
- Infosys Consulting- Europe (7 Jobs)
- Abb Vie (6 Jobs)
- Coriolis Pharma Research GmbH (5 Jobs)
- Regeneron (4 Jobs)
- IQVIA (4 Jobs)
In welchen Bundesländern werden die meisten Drug Regulatory Manager Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Manager Jobs werden derzeit in Bayern (30 Jobs), Nordrhein-Westfalen (16 Jobs) und Sachsen-Anhalt (11 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Manager Jobs?
Drug Regulatory Manager Jobs gehören zum Berufsfeld Regulatory Affairs & Management.