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Regulatory Project Manager
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Full-time
- Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
- Your RoleWe are seeking a highly motivated and experienced Regulatory Project Manager with a strong background in sterile injectables.
- Responsible for coordinating resources, tracking progress, ensuring timely deliverables, and leading cross-functional teams to support product development, commercialization efforts, and regulatory requirements for a range of product types.
- This position is based in York, PA.Lead and manage regulatory projects from initiation to completion, ensuring timelines and milestones are met.
- Prepare, review, and submit regulatory documents as needed, including INDs, NDAs, BLAs, MAAs, and amendments/supplements to global health authorities (e.g., FDA, EMA).
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