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Regulatory affairs CMC Consultant
2 weeks ago
Regulatory affairs CMC Consultant
Remote
Tasks & Responsibilities :
- 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
- Support due diligence processes
- 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 strategic aspects with CDMOs
- Coordination of filing activities within the cross-functional team and with contributing parties
- Continued observance of regulatory guidance and regulations
Requirements:
- Ph.D. or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable
- At least five years in a scientific/technical CMC development or CMC – regulatory affairs function
- Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
- Excellent communication and negotiation skills in English. German language skills are a plus
- Experience with CMC and regulatory requirements for all development stages, from preclinical to Phase III or commercial
- Highly motivated team player with strong interpersonal abilities
- Sound knowledge of Microsoft Office applications
- Willingness to travel moderately (Meetings with clients, agencies or CMOs)
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