Hobson Prior are currently looking for a CMC Consultant to join a regulatory consulting and services organisation on a permanent basis in Munich, Germany. This role will be the quality expert in the team, providing knowledge on broad range of drug substances and drug products.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• To provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team.
• Perform gap analyses of client-provided packages. Identify critical CMC development issues and develop strategies for their resolution.
• Support due diligence processes.
• 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.
• 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.

Requirements:

• Ph.D. or master's degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable.
• A minimum of 5 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 pre-clinical 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).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.