Regulatory Affairs Lead

My client is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. They have retained us to fill a growth opportunity for a Regulatory Affairs Lead to join their science driven, patient focused culture. In this role, you will be leading strategy (US and Global) for innovative programs in development. Reporting to the Head of Global Regulatory Affairs, you will serve in a highly visible role and collaborate with a number of cross-functional stakeholders both internally and externally. In this position, you will have the ability to work in an environment where you can make an immediate impact and be part of a creative, science focused team.

Responsibilities:

  • Drive, oversee and ensure consistency of the regulatory strategy (US & Global) and related activities associated with the projects under his/her accountability
  • Coordinate activities to maintain regulatory filings including planning and preparing IND/CTA amendments, annual reports, DSURs
  • Coordinate all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements
  • Key driver for the lifecycle of the asset
  • Support the development of briefing documents for formal regulatory meetings
  • Act as, or manage, the single point of Regulatory contact for assigned programs and project teams
  • Provide input into all development stages of the products within a given product portfolio. Contribute, from an RA perspective, to the establishment of the product development strategy and its execution in order to ensure a complete and rapid development of the asset
  • Support the development of regulatory strategies and plans to advance products through the regulatory review and approval process globally

Knowledge and Skills:

  • Minimum BA/BS degree in life sciences required, MS/PhD preferred
  • Minimum 4-6 years’ experience or 2-4 with a MS/PhD in a Regulatory Affairs
  • Knowledge of the drug development process, with a focus on IND/CTA and BLA/MAA processes.
  • Demonstrated experience in preparing IND and/or BLA submissions is desirable.
  • Must have Biologics experience, Cell/Gene a plus
  • Must have experience in working with cross functional teams
  • Thorough knowledge of the drug development process, with a focus on IND/CTA and NDA/BLA/MAA processes
  • Excellent ability to read, analyze

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