CMC Regulatory Affairs

BioTalent; Bayern; Hybrid; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading global consultancy firm is seeking a CMC Regulatory Affairs Consultant to provide regulatory advice on drug development across various projects. The successful candidate will collaborate with clients to ensure compliance and seamless project execution throughout all development phases. This hybrid role requires expertise in regulatory CMC and a strong commitment to quality and client success.

Qualifikationen

• At least five years in Regulatory CMC.
• Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
• Experience in all development stages, from pre-clinical to Phase III or commercial.

Aufgaben

• Provide advice to clients on quality aspects of drug development.
• Ensure CMC documentation meets regulatory requirements.
• Prepare briefing packages for agency meetings.

Kenntnisse

Communication

Negotiation

Regulatory CMC Knowledge

Ausbildung

Ph.D. in Chemistry, Biopharmaceuticals, Biochemistry, Biology or MSc

Jobbeschreibung

Job Title: CMC Regulatory Affairs Consultant - 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.