Regulatory Affairs CMC Manager

This is an exciting long term contract working on behalf of a global pharmaceutical company in Switzerland, Basel as a Global CMC Regulatory Affairs Manager. You will support all global CMC submission activities.

Responsibilities:

• Produce high quality project documentation and presentations.
• Ensure regulatory strategy running on time and to plan. 
• Drive approvals of clinical studies, global registration dossiers or variations.
• Lead on CMC submission's
•  Provides high quality regulatory evaluation and strategic advice
• Maintains collaborative partnerships with stakeholders.
• Support all global CMC submission activities
• Author and/or review high-quality CMC documentation for Health Authority submission, 

Requirements:

• Bsc degree or advanced degree in Life Sciences
• Proven experience in Global Regulatory CMC submissions (planning, authoring, reviewing, coordination, submission) 
• Experience in authoring technical regulatory CMC documents to support submissions. (Module1 - 3 etc) 
• Track record to successfully work in interdisciplinary global teams
• Business proficient English (written, spoken and reading)