Regulatory Affairs CMC Manager, Drug Substance

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.
• Cont...