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Director, Global Regulatory Lead FA
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Full-time
- We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients.
- The Director will be responsible for providing global regulatory leadership in support of the development, registration, and life-cycle management of our innovative gene therapy programs, as well as for the oversight and mentoring of a growing regulatory team.
- The responsibilities include providing global regulatory leadership and direction for Rocket’s gene therapy products, including developing long and short-term planning of regulatory projects that align with the company's business plan, and developing strategies to ensure effective achievement of regulatory/business objectives.
- Liaises and negotiates with US FDA, EMA, MHRA and other regulatory agencies as needed for all aspects pertaining to drug development including novel regulatory pathways for the company's gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
- Takes a hands-on approach in leading the completion of IND/CTA, NDA/BLA/MAA, and other global submission documents.
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