Regulatory Affairs CMC Manager (m/f/x)- Bayern, Germany We are seeking a Senior Regulatory Affairs CMC Manager to join one of our key client’s team as a quality expert. This role involves providing expertise on a broad range of drug substances (small molecules, biologicals). The position covers quality-related topics from pre-clinical development through to approved commercial products. Key Responsibilities: Quality aspects of drug development and regulatory requirements, collaborating with cross-functional team experts. Ensure CMC work-packages and documentation are phase-appropriate, meet regulatory expectations, and support regulatory submission approvals. Prepare quality sections for MAA, BLA/NDA, IMPD, and IND. Analyses, identify critical CMC development issues, and develop resolution strategies. Support due diligence processes. Manage operational and strategic aspects with CDMOs. Coordinate filing activities within the cross-functional team and with contributing parties. Stay up to date with regulatory guidance and regulations. Qualifications: Ph.D. or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a related field. Minimum of five years in a scientific/technical CMC development or CMC regulatory affairs role. Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA). Excellent communication and negotiation skills in English; German is a plus. Familiarity with CMC and regulatory requirements from pre-clinical to Phase III or commercial stages. Strong team player with excellent interpersonal skills. Proficient in Microsoft Office applications. Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application! Email: s.revesz@sciproglobal.de Tel: 0049 (0) 89 26 200 311 (direct dial) LinkedIn: www.linkedin.com/in/sara-revesz-1938b2239