CMC Consultant (m/f/d)
EPM Scientific are currently partnered with a specialised life sciences consultancy supporting a wide range of pharmaceutical and biotech clients across multiple therapeutic areas.
They are seeking a CMC Consultant to support their regulatory and CMC team.
Key Responsibilities:
- Provide expert advice to clients on CMC strategy, quality requirements, and regulatory pathways across all stages of drug development.
- Ensure CMC documentation and work packages are phase-appropriate and aligned with global regulatory expectations (EMA, FDA, and other agencies).
- Lead or contribute to preparation of CMC sections for regulatory submissions including IND/IMPD, NDA/BLA, and MAA.
- Conduct gap analyses of existing CMC data packages and define strategies to address development and compliance challenges.
- Support due diligence activities for licensing, partnerships, or acquisitions from a CMC perspective.
- Prepare briefing documents for interactions with health authorities and support client representation in scientific advice or regulatory meetings.
- Collaborate with CDMOs and external partners, overseeing both operational execution and strategic alignment.
- Coordinate cross-functional contributions to regulatory filings and ensure timely, high-quality submission delivery.
- Maintain up-to-date knowledge of evolving global CMC and regulatory guidelines and apply these insights to client projects.
Requirements:
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biochemistry, Biology, or a related scientific discipline.
- Minimum of 5 years' experience in CMC development, technical operations, or CMC regulatory affairs within the pharmaceutical or biotech industry.
- Proven experience with global regulatory submissions (IND/IMPD, NDA/BLA, MAA).
- Strong understanding of CMC requirements across the full product lifecycle (early development to commercialisation).
- Experience working with a range of modalities (e.g., small molecules, biologics, or advanced therapies) is highly desirable.
- Excellent communication and stakeholder management skills, with the ability to operate in a client-facing, advisory capacity.
- Strong organisational skills and ability to manage multiple projects in a consulting environment.
- Fluent in English; additional European language(s) considered an advantage.
If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.
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