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Regulatory Affairs Manager
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Full-time
- Title: Regulatory Affairs Manager
- Managing regulatory compliance activities for the company and existing customer products and registrations as required and providing strategic planning for regulatory changes.
- Membership of project teams, including estimating regulatory resource needs for incorporation into project plans and monitoring of regulatory activities versus the project plan; reporting of issues / delays to management.
- E.g., IND feedback, MAA project feedback, Pre IND meeting outcomes to ensure continuous improvement.
- Advising on CMC elements of variation / supplement packages as required.
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