Regulatory CMC Specialist
vor 1 Woche
Regulatory CMC Manager / Senior ManagerLocation: Munich (On-site, full-time, permanent)Overview We are seeking a Regulatory CMC professional with hands-on experience authoring and leading CMC regulatory submissions across early and late stage development. This role is central in ensuring CMC strategy, documentation, and communication align with global regulatory expectations, supporting successful approvals and lifecycle management.Key ResponsibilitiesLead and author CMC sections for regulatory submissions including IND, IMPD, MAA, NDA, and BLA, ensuring technical accuracy and regulatory compliance.Develop and implement RegCMC strategies across drug substance and drug product development programs.Coordinate with internal Technical Development, Quality, Manufacturing, and Project teams to ensure alignment of CMC data, timelines, and documentation.Represent CMC in scientific advice and regulatory agency interactions, contributing to strategy and preparation of briefing packages.Prepare and maintain CMC components of briefing books, regulatory responses, and variation filings.Provide regulatory guidance on changes, stability, specifications, analytical methods, comparability, and process validation approaches.Support lifecycle management activities and post-approval CMC commitments.RequirementsDegree in Pharmaceutical Sciences, Chemistry, Biology, or related field; advanced degree preferred.Proven hands-on RegCMC experience including direct authorship of CMC sections for IND/IMPD and at least one major global marketing application (MAA, NDA, or BLA).Experience participating in regulatory meetings / scientific advice with EU and/or US agencies.Solid understanding of ICH, EMA, FDA guidance related to quality, development, and commercialization.Excellent written communication, documentation structure, and cross-functional collaboration skills.Ability to work on-site in Munich full-time.Experience across small molecules, biologics, or advanced modalities.Familiarity with outsourced manufacturing models (CMOs/CDMOs).What We OfferPermanent, on-site role in a collaborative R&D environment.Opportunity to directly shape regulatory strategy from development to approval.Competitive compensation and benefits package.
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Regulatory CMC Specialist
vor 1 Woche
Munich, Bayern, Deutschland S3 Science Recruitment VollzeitRegulatory CMC Specialist | Biopharma | MunichWe are seeking an experienced Regulatory CMC professional with hands-on involvement across global development and registration activities. This role is ideal for someone who has directly contributed to CMC strategy and authored key submission documentation.What You'll DoLead and contribute to CMC content for...
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Regulatory affairs
vor 1 Woche
Munich, Deutschland S3 Science Recruitment VollzeitRegulatory Affairs Specialist – CMCLocation: Germany (Hybrid / On-Site)Employment Type: PermanentOverviewWe are seeking an experienced Regulatory Affairs Specialist with strong CMC expertise to join our growing team. This role is ideal for someone with a rigorous scientific background (Master’s or PhD required) and hands-on experience supporting...
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Regulatory Affairs Cmc
vor 1 Woche
Munich, Deutschland Stirling Q&R Ltd Vollzeit**Position: Regulatory Affairs CMC** **About the Company**: A renowned pharmaceutical consulting firm is currently seeking a Regulatory Affairs CMC expert with a strong background in **small molecules** and pharmaceuticals. This role offers the opportunity to provide expert guidance on regulatory strategies for drug development projects, ensuring adherence...
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Regulatory Cmc Lead
Vor 4 Tagen
Munich, Deutschland Stirling Q&R Ltd Vollzeit**Tasks & Responsibilities**: - Provide strategic advice to clients on quality aspects of drug development and regulatory requirements, collaborating closely with cross-functional experts within the team. - Ensure that the content of CMC work-packages and documentation align with the appropriate development phase, meet regulatory expectations, and...
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Regulatory affairs
vor 1 Woche
Munich, Bayern, Deutschland S3 Science Recruitment VollzeitRegulatory Affairs Specialist – CMCLocation:Germany (Hybrid / On-Site)Employment Type:PermanentOverviewWe are seeking an experienced Regulatory Affairs Specialist with strong CMC expertise to join our growing team. This role is ideal for someone with a rigorous scientific background (Master's or PhD required) and hands-on experience supporting regulatory...
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Senior CMC Manager
Vor 5 Tagen
Munich, Deutschland Barrington James VollzeitThe Senior CMC Manager will play a key leadership role in defining and delivering CMC strategy across the company's gene therapy pipeline. You will oversee internal and external activities spanning process development, GMP manufacturing, analytical development, and regulatory documentation. This position requires strong technical depth, exceptional...
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Senior CMC Manager
vor 1 Woche
Munich, Bayern, Deutschland Barrington James VollzeitThe Senior CMC Manager will play a key leadership role in defining and delivering CMC strategy across the company's gene therapy pipeline. You will oversee internal and external activities spanning process development, GMP manufacturing, analytical development, and regulatory documentation. This position requires strong technical depth, exceptional...
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Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit 50.000 € - 80.000 € pro JahrJob Title: Associate (m/f/x) CMC Regulatory Affairs - fixed-term (1 year)Posting Start Date: 04/12/2025Job Description:For our headquarters in Munich we are seeking highly qualified candidates to fill the position:Associate (m/f/x) CMC Regulatory Affairsfixed-term (1 year) -The Position:Within Daiichi-Sankyo's Technology Unit, the role of the Regulatory...
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RegCMC Consultant/ Specialist
vor 1 Woche
Munich, Deutschland S3 Science Recruitment VollzeitRegulatory CMC Consultant – Permanent Position (Germany)Join a high-impact consultancy shaping global drug developmentAre you an experienced CMC professional ready to influence innovative drug development programs across the globe? This is an opportunity to step into a strategic consultancy role supporting cross-functional development teams working on...
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RegCMC Consultant/ Specialist
vor 1 Woche
Munich, Bayern, Deutschland S3 Science Recruitment VollzeitRegulatory CMC Consultant – Permanent Position (Germany)Join a high-impact consultancy shaping global drug developmentAre you an experienced CMC professional ready to influence innovative drug development programs across the globe? This is an opportunity to step into a strategic consultancy role supporting cross-functional development teams working on...
