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Regulatory Affairs Consultant

4 months ago

United Kingdom Life Science People Full time

Regulatory affairs CMC Consultant Remote

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
Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client
Continued observance of regulatory guidance and regulations

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
Sound knowledge of Microsoft Office applications
Willingness to travel moderately (Meetings with clients, agencies or CMOs)