Job Description
To strengthen our growing Regulatory Affairs consulting business, the Entourage team in Switzerland is looking for an experienced Senior Regulatory Affairs Consultant with strong expertise in pharmaceutical APIs and international regulatory environments, particularly APAC (China).
Additional experience in IVD Regulatory Affairs would be a strong advantage. We are looking for a hands‑on RA all‑rounder – from strategy to execution - with the ability to quickly adapt to new environments, work cross‑functionally, and ensure operational stability during critical project phases.
Your Responsibilities
- Manage and maintain DMFs, ASMFs, CEPs, and related CMC documentation
- Support global submissions, renewals, variations, and lifecycle management activities
- Coordinate eCTD publishing activities and external publishing providers
- Maintain regulatory databases, registration trackers, and product overviews
- Assess regulatory...