CMC Regulatory Consultant - Permanent

Munich
1 week ago
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Title: CMC Regulatory Consultant
Location: Munich, Germany (1–2 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.Audit Coordination:
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.Your Background:
PhD or Master’s 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.Apply:
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 (phone number removed) in all correspondence

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