Director EU Regulatory Affairs

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Director, EU Regulatory Affairs
Responsibilities: Leads the development and implementation of the EU regulatory strategy across Rocket’s gene therapy pipeline, in coordination with the overall global regulatory strategy to support efficient development and approval of Rocket’s gene therapy products. Owns the development and timely submission of high-quality regulatory documents to EU health authorities (e.g., IMPDs, Orphan Drug Applications, Pediatric Investigational Plans (PIPs), Marketing Applications). Serves as the primary point of contact with EU regulatory agencies, including leading formal and informal meetings with relevant agencies (including managing the generation of any associated briefing books, conducting internal preparation, etc.) and responding to health authority inquiries. Ensures regulatory compliance, i.e., advice received from and commitments made to EU health authorities are fully implemented in Rocket development programs. Stays abreast of, analyzes, and effectively communicates relevant changes to the EU regulatory landscape to Rocket management, including for example, new regulations, guidelines, and policies, pertinent to rare disease and gene therapy development. Guides the implementation of any relevant EU regulatory changes to Rocket programs. Collaborates with and manages regulatory consultants and other vendors as required.

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