Company:  Confidential

Job Title: Director of EU Regulatory Affairs

Job Number: 23638

Location: New York, NY

Job Description


  • Leads the development and implementation of the EU regulatory strategy across 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 development programs
  • Stays abreast of, analyzes, and effectively communicates relevant changes to the EU regulatory landscape to 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 programs
  • Collaborates with and manages regulatory consultants and other vendors as required

Required Skills

  • Strong scientific background. BA/BS/University degree in Life/Health Sciences required; advanced degree preferred (PharmD, MD, PhD, JD)
  • 6-8 years of EU regulatory experience with a premarket focus
  • Cell and gene therapy experience strongly preferred
  • Proficient with other international regulations, including ICH guidelines
  • Strong leader but also strong team player who demonstrates initiative, willingness to roll-up his/her sleeves, and problem solve
  • Ability to thrive in a fast‐paced environment
  • Strong writing skills is a must, including ability to author documents
  • Ability to communicate effectively


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