Regulatory Affairs CMC Manager, Drug Substance

Vor 3 Tagen


Basel, Schweiz Trades Workforce Solutions Vollzeit

Regulatory Affairs CMC Manager (Drug Substance – ADC focus) – Basel, Switzerland 📍 4 days on site / 1 day remote💶 Salary range: 105K–120K CHF Responsibilities: Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates. Author and review clinical regulatory submissions from scratch (IMPD/IND, CTD Modules 2 & 3). Develop and document development pathways to support pipeline progression from early clinical to late-stage. Provide regulatory review of source documents (method validation, batch records, comparability data, stability). Collaborate closely with CDMOs and external manufacturing partners, overseeing tech transfer and ensuring regulatory alignment. Engage in cross‑functional discussions with R&D, MSAT, and QA to ensure a seamless flow of CMC information into regulatory submissions. Contribute to internal process improvements and establish best practices for regulatory operations. Ideal Background: Strong CMC Drug Substance expertise gained in R&D, process development, or MSAT, with readiness to take on a regulatory‑facing role. Hands‑on experience with ADCs or related bioconjugate platforms. Solid understanding of ICH guidelines, EU/FDA expectations, and CMC dossier requirements. #J-18808-Ljbffr



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