Associate Director – Technical Regulatory Affairs

Associate Director – Technical Regulatory Affairs – 6838

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Technical Regulatory Affairs – Associate Director.

The start date is asap for a 12 month-contract based in Basel area to cover a maternity leave.

Our client is seeking an experienced Technical Regulatory Affairs – Associate Director to support an active clinical development program.

In this key role, you will shape and execute technical/CMC regulatory strategies for global development and registration.

• Design and lead Technical Regulatory Affairs strategy for assigned projects.
• Prepare regulatory quality documents (CTD Modules 2 & 3, IMPD, IND).
• Prepare briefing books for Health Authority meetings.
• Coordinate with CMC, DRA, QPs, CMOs and regulatory partners.
• Lead cross-functional discussions and documentation challenges.
• Evaluate regulatory impact of product/process changes.
• Ensure global regulatory and GMP compliance.
• Manage documentation storage and track global submissions.

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• Master’s degree or higher in a scientific field.
• 7+ years experience in technical/CMC regulatory affairs.
• Strong knowledge of ICH, GMP and global regulatory procedures.
• Understanding of drug substance/product development and manufacturing.
• Excellent communication, leadership and organizational skills.
• Proficient in MS Office and documentation systems.