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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 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.
