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Manager Global Regulatory Affairs

Company

The Fountain Group

Address United States
Employment type CONTRACTOR
Salary
Expires 2023-08-18
Posted at 10 months ago
Job Description
  • Risk identification in terms of CMC regulatory strategy
  • Interpret, apply and implement global regulations to CMC projects and prepare CMC regulatory submissions.
  • Support the Initiation and maintenance of appropriate communication within the RA function and stakeholders
  • Strong negotiation skills and significant experience in interacting with regulatory authorities
  • Expert knowledge of regulations, and experience with interpretation and application
  • Experience in the development and implementation of CMC regulatory strategies throughout the lifecycle of pharmaceuticals/devices
  • Exp withGlobal responsibility for regulatory submissions and registrations preferred
  • Experience in a pharmaceutical manufacturing facility/development laboratory preferred.