CMC Regulatory Consultant Permanent
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Job Summary
Title: CMC Regulatory Consultant
Location: Munich Germany (12 days remote working)
Position: Permanent opportunity
Rate: Competitive market salary
CK Group are recruiting on behalf of a science-led pharmaceutical and biotechnology consultancy providing expert CMC quality and regulatory support across drug development.
The Role: This is a client-facing CMC Regulatory Consultant position acting as a technical and quality expert across a broad range of drug substances and drug products. The role covers CMC and quality topics from pre-clinical development through to approved commercial products working closely with internal experts clients and external partners.
Key Responsibilities:
Please send your CV and cover letter in English. It is essential that applicants hold entitlement to work in Germany or make it clear if a visa is required. Relocation support is provided. Please quote job reference 174056 in all correspondence.
Location: Munich Germany (12 days remote working)
Position: Permanent opportunity
Rate: Competitive market salary
CK Group are recruiting on behalf of a science-led pharmaceutical and biotechnology consultancy providing expert CMC quality and regulatory support across drug development.
The Role: This is a client-facing CMC Regulatory Consultant position acting as a technical and quality expert across a broad range of drug substances and drug products. The role covers CMC and quality topics from pre-clinical development through to approved commercial products working closely with internal experts clients and external partners.
Key Responsibilities:
- Provide scientific and regulatory advice on CMC and quality aspects of drug development.
- Ensure CMC work packages and documentation are phase-appropriate and aligned with regulatory expectations.
- Prepare quality sections for regulatory submissions including IND IMPD BLA NDA and MAA.
- Perform gap analyses on client CMC packages and develop mitigation strategies.
- Support due diligence activities.
- Prepare briefing packages and participate in regulatory agency meetings including scientific advice and milestone meetings.
- Manage operational and strategic interactions with CDMOs.
- Coordinate filing activities across cross-functional teams and external contributors.
- Maintain awareness of evolving regulatory guidance and requirements.
- Support quality and CMC readiness for regulatory submissions and inspections.
- Contribute to structured review follow-up and coordination of quality documentation.
- Liaise with internal teams and external partners to ensure compliance with regulatory expectations.
- PhD or Masters degree in Pharmacy Chemistry Biopharmaceuticals Biochemistry Biology or a related discipline.
- At least five years experience in CMC development or CMC regulatory affairs within a scientific or technical environment.
- Hands-on experience with regulatory filings such as IND IMPD BLA NDA or MAA.
- Strong understanding of CMC and regulatory requirements across all development stages.
- Confident communicator in English; German language skills are an advantage.
- Comfortable working in a collaborative client-focused consulting environment.
- Willingness to travel moderately for client agency or CMO meeting.
Please send your CV and cover letter in English. It is essential that applicants hold entitlement to work in Germany or make it clear if a visa is required. Relocation support is provided. Please quote job reference 174056 in all correspondence.
Company Industry
Pharmaceuticals
About Company
Idibu
100 employees
Every business is now operating in an environment that’s susceptible to change. idibu has evolved against this changing backdrop. Whether driven by legislation, technology, customer demand or the economy, businesses now need to be agile and fleet of foot to ensure they can attr ... View more
