Regulatory Affairs CMC Consultant

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