Director, EU Regulatory Affairs

Director, EU Regulatory Affairs

Rocket offers a unique opportunity to be at the forefront of innovation while working alongside motivated team members to bring best-in-class curative gene therapies for patients with devastating diseases. The ideal candidate is an action-oriented, life-long learner who is inspired to make an impact for patients. The Director for EU Regulatory Affairs will lead the development and implementation of the EU regulatory strategy for Rocket’s gene therapy programs in accordance with EU regulations and through collaboration with external partners, internal cross-functional teams, and global health authorities.

Job 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

Job Requirements

  • 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 fastpaced environment
  • Strong writing skills is a must, including ability to author documents
  • Ability to communicate effectively

Interested in joining our team?

Contact us today!

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