Director Regulatory Affairs CMC

BioTalent; Bayern; Hybrid; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading Global Life Science Consultancy Firm seeks a Director of Regulatory CMC with expertise in drug development and regulatory compliance. The role involves advising clients, preparing regulatory documents, and managing development stages from pre-clinical to commercial. This position is hybrid, requiring at least three days on-site in Southern Germany, and offers a competitive compensation package based on experience.

Qualifikationen

• Ph.D. or MSc with at least five years in Regulatory CMC.
• Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
• Willingness to travel moderately.

Aufgaben

• Advise clients on quality aspects of drug development and regulatory requirements.
• Ensure CMC documentation meet regulatory expectations.
• Prepare quality sections for regulatory submissions.

Kenntnisse

Excellent communication

Negotiation skills

Strategic thinking

Ausbildung

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

MSc with relevant experience

Jobbeschreibung

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. 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
• 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.

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

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