CMC Consultant

BioTalent Ltd; München; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Client engagement

Regulatory compliance

Analytical skills

Technical writing

Communication skills

Ausbildung

PhD or MSc in Pharmacy, Chemistry, Biochemistry

Jobbeschreibung

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