Director Regulatory Affairs CMC

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They are currently expanding the team as they now have a vast number of various projects coming in across various therapeutic areas and modalities.

You will have the opportunity to work across various projects from Pre-Clinical to Commercial assets. • Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team • Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval of regulatory submissions • Preparation of quality sections for MAA and BLA/NDA as well as for IMPD and IND • Perform gap analyses of client-provided packages.

Identify critical CMC development issues and develop strategies for their resolution • Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client • Management of operational and strategical aspects with CDMOs • Coordination of filing activities within the cross-functional team and with contributing parties • Continued observance of regulatory guidance and regulations Qualifications: • Ph.D, in Chemistry, Biopharmaceuticals, Biochemistry, Biology or MSc with relevant experience. • At least five years in Regulatory CMC • Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA). • Excellent communication and negotiation skills in English. • Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial • Willingness to travel moderately (Meetings with clients, agencies or CMOs) • This is a hybrid role in Southern Germany and would require at least 3 days per week on site, however for the right individual remote working could be considered.

Direct message the job poster from BioTalent Job Title: Director Regulatory CMC - Global Life Science Consultancy Firm Location: Bavaria, Germany Company Overview: Our client are a leading consultancy company who have over 1000 global clients across biotech and pharmaceuticals.

Position Overview: We are seeking a dedicated and talented individual with expertise in Regulatory CMC and will act as the expert for various clients.

Seniority level • Seniority level Mid-Senior level Employment type • Employment type Full-time Job function • Job function Research and Science • Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at BioTalent by 2x Sign in to set job alerts for “Director of Regulatory Affairs” roles.

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