Job Description:
Supporting Mylan's mission to provide high quality access to healthcare by developing regulatory strategies for Injectables and applying the strategy to achieve a first found submission approvals.
- Implement and ensure compliance of regulatory strategies with current regulations and guidance
- Collaborate with teams to communicate and implement regulatory strategies
- Maintain expert level knowledge of regulations and guidance for one or more product types (Injectables, Ophthalmic, etc) within designated regions
- Liase with Health Authorities and ensure timely responses to Health Authority inquiries
- Direct and review the content preparation and ensure high quality documentation within submissions
- Review and approve regulatory submission documents and Health Authority communications
- Perform final sign off of regulatory submissions
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