Regulatory Affairs CMC Manager, Drug Substance

2 weeks ago

London, Greater London, United Kingdom Barrington James Full time 105,000 - 120,000 per year

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.

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