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