Regulatory affairs

vor 1 Woche

Munich, Deutschland S3 Science Recruitment Vollzeit

Regulatory 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 submissions across early and late-stage development.Key ResponsibilitiesPrepare, review and maintain CMC documentation for global regulatory submissions (IND, IMPD, CTA, MAA, NDA, BLA).Support regulatory strategy for CMC topics across drug substance and drug product.Contribute to scientific advice meetings, briefing books, and responses to health authority queries.Ensure alignment of CMC development activities with applicable guidelines (EMA, FDA, ICH).Collaborate closely with Quality, Process Development, Analytical, and Clinical teams to ensure regulatory compliance.Maintain oversight of CMC change controls and post-approval variations.RequirementsMaster’s or PhD in Life Sciences, Pharmacy, Chemistry, Biochemistry or related field (mandatory).3–7+ years of experience in Regulatory Affairs with a CMC focus.Demonstrated experience authoring, reviewing, or contributing to CMC modules for global submissions.Strong understanding of drug development processes, GMP, and regulatory expectations.Excellent written and verbal communication skills.Ability to work cross-functionally and manage multiple priorities.What We OfferOpportunity to work on diverse development programs across multiple modalities.A collaborative, science-driven environment with strong career development potential.Competitive compensation and benefits.

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