Regulatory Affairs CMC Manager

Basel, Switzerland

Posted:51 days ago
Location:Basel, Switzerland
Job Ref:BH-34180
Job Type:Contract
Salary:Competitive
Expiry date:2/2/2023
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) 

Apply now