Darum lohnt es sich
The role covers a wide range of modalities including small molecules, biologics, oligonucleotides, and advanced drug products.Key ResponsibilitiesProvide CMC quality and regulatory guidance across global development programsAuthor and review CMC sections for regulatory submissions (IND/IMPD, NDA/BLA/MAA)Perform gap analyses and define mitigation strategies for CMC packagesSupport regulatory meetings and prepare briefing documentationCoordinate with CDMOs and cross-functional teams on development and filing activitiesEnsure compliance with evolving global regulatory requirementsRequirementsDegree (PhD or Master’s) in Pharmacy, Chemistry, Biology or related field5+ years’ experience in CMC development or regulatory CMC rolesStrong experience with global regulatory submissionsBroad knowledge of CMC across development stagesExcellent communication and stakeholder management skills (English required; German is a plus)OfferSenior, client-facing consulting role in a specialist teamBroad exposure across innovative development programsCompetitive compensation with performance-based bonusModerate 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.
