Regulatory Affairs CMC Manager, Drug Substance, ADC

Must be based/willing to travel to 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.
  
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