CK Group are recruiting for a CMC Regulatory consultant to join a international regulatory affairs consulting business , based in Munich, Germany on a full time & permanent basis.
Salary:
Everyone says "negotiable" or "competitive", but in this case it truly is! For a candidate with the right skills and experience, we can be competitive and offer a rewarding salary & package. When you apply, please quote your current package and expectations.
Company:
Our client is an established consulting business in the field of regulatory affairs. The staff of experienced consultants have built a strong reputation for excellence, and the company is looking to bring in additional staff to supplement the existing team.
Location:
Munich, Germany. It is expected that you will work from the offices 60% of the time ~3 days per week.
Regulatory CMC Consultant:
The Consultant CMC is the subject matter expert in the consulting team, providing knowledge on broad range of drug substances (from small molecules to synthetic oligonucleotides to biologicals) and drug products (from solid orals to sterile solutions to nanoparticulate formulations). This function will cover all quality related topics from pre-clinical development to approved commercial products.
Tasks & Responsibilities:
- 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 clien
- Management of operational and strategical aspects with CDMOs
- Coordination of filing activities within the cross-functional team and with contributing partie
- Continued observance of regulatory guidance and regulations
Your Background:
- Ph.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 pre-clinical to Phase III or commercial
- Highly motivated team player with strong interpersonal abilitie
- Sound knowledge of Microsoft Office applications
- Willingness to travel moderately (Meetings with clients, agencies or CMOs)
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55251 in all correspondence.
You must have the right to work in Germany.
- Agency: CK Group
- Reference: 55251
Website: CK Group
- Posted: 15th March 2023
- Expires: 12th April 2023
