Regulatory Affairs CMC Consultant
Green Life Science –
Leipzig
We are looking for an experienced CMC Quality Expert to support clients across all stages of drug development, from pre-clinical through to commercialisation. The role covers a wide range of modalities including small molecules, biologics, oligonucleotides, and advanced drug products.
Key Responsibilities
- Provide CMC quality and regulatory guidance across global development programs
- Author and review CMC sections for regulatory submissions (IND/IMPD, NDA/BLA/MAA)
- Perform gap analyses and define mitigation strategies for CMC packages
- Support regulatory meetings and prepare briefing documentation
- Coordinate with CDMOs and cross-functional teams on development and filing activities
- Ensure compliance with evolving global regulatory requirements
Requirements
- Degree (PhD or Master’s) in Pharmacy, Chemistry, Biology or related field
- 5+ years’ experience in CMC development or regulatory CMC roles
- Strong experience with global regulatory submissions
- Broad knowledge of CMC across development stages
- Excellent communication and stakeholder management skills (English required; German is a plus)
Offer
- Senior, client-facing consulting role in a specialist team
- Broad exposure across innovative development programs
- Competitive compensation with performance-based bonus
- Moderate travel as required
