Manager, Regulatory, EU (1 year contract)

5-8 years of experience supporting EU regulatory submissions, including hands-on preparation and filing responsibilities of major EU submissions (EU MAA preferred). Strong proficiency with Veeva RIM for managing submissions, regulatory information and document workflows. Working knowledge of EMA systems (IRIS, SPOR, and other submission portals). Demonstrated expertise in compiling and reviewing eCTD Module 1 documentation and completing eAFs. Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (Master’s preferred). Excellent attention to detail with the ability to manage multiple priorities under tight timelines. Strong communication and collaboration skills. Willingness to travel to the Zug, Switzerland office quarterly or as needed.

Support preparation, compilation, and submission of EU regulatory filings. Execute eCTD Module 1 authoring, compilation, and QC. Manage regulatory data, metadata, records, and workflows in Veeva RIM. Coordinate timely submissions via EMA portals. Compile, review, and perform quality checks for Module 1 components. Ensure all submission packages meet regional requirements and internal quality standards. Collaborate with cross-functional teams to gather and verify documentation. Maintain submission records and monitor timelines.