Regulatory Affairs CMC Manager, Drug Substance
- Horley, Surrey
- Permanent
- Full-time
💶 Salary range: 105K-120K CHFResponsibilities: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.