Director Regulatory Affairs CMC

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

Position Overview :

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