Pharma jobs in United States
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CMC Consultant
Job summary
A leading regulatory consultancy in Munich is seeking a CMC Consultant to provide strategic guidance on quality matters throughout the drug development lifecycle. The ideal candidate will have a PhD or MSc and at least 5 years of experience in CMC development or regulatory affairs. This role involves preparing CMC documentation and interacting with agencies, impacting clients' ability to bring new therapies to market. The company supports relocation with visa sponsorship available.
Qualifications
- 5+ years of experience in CMC development or regulatory affairs.
- Experience contributing to global submissions (IND, IMPD, MAA, BLA, NDA).
- Fluent in English; German is an advantage.
Responsibilities
- Provide strategic and operational guidance on CMC quality matters.
- Prepare and review global CMC documentation (IMPD/IND, MAA, BLA/NDA).
- Lead agency interactions and prepare briefing packages.
Skills
Education
Title: CMC Consultant
Location: Munich, Germany
Relocation: Supported – visa sponsorship available (Blue Card)
The Company
This is one of Europe’s leading regulatory consultancies, providing strategic support for global drug and device development programs. Over the past 20 years, they’ve partnered with more than 1,000 clients to solve complex regulatory and scientific challenges across all therapeutic areas and drug modalities.
Privately owned and based in Munich, the firm is known for its scientific depth, technical quality, and long-standing client relationships. With a 98% consultant retention rate, they offer a collaborative, high-performing work environment where autonomy and hands-on expertise are valued. The culture is serious, science-driven, and built for people who thrive in complex, high-stakes regulatory work.
The Role
This is a technically focused, client-facing consulting role at the interface of quality and regulatory affairs. You’ll lead on CMC topics throughout the development lifecycle – from pre-clinical through to commercial – and work across a broad range of products including small molecules, biologics, and oligonucleotides. Your input will shape key regulatory filings and agency interactions, with a direct impact on your clients’ ability to bring new therapies to market.
Responsibilities
Provide strategic and operational guidance on CMC quality matters
Prepare and review global CMC documentation (IMPD/IND, MAA, BLA/NDA)
Conduct gap analyses and design remediation strategies
Lead agency interactions and prepare briefing packages
Advise clients through all phases of drug development
Coordinate inputs from CDMOs and internal cross-functional teams
Monitor and interpret global CMC regulatory trends
Candidate Profile
PhD or MSc in Pharmacy, Chemistry, Biochemistry, or a related field
At least 5 years of experience in CMC development or regulatory affairs
Track record of contributing to global submissions (IND, IMPD, MAA, BLA, NDA)
Comfortable working directly with clients and regulatory authorities
Strong written and verbal communication skills
High attention to technical detail and regulatory compliance
Fluent in English (German is an advantage)
Willing to travel occasionally for client or agency meetings
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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