Regulatory Affairs Director or Associate Director

This growing biotech company is focused on transforming the lives of patients with severe genetic and orphan diseases.  They are seeking a Regulatory Affairs Director or Associate Director to develop regulatory strategies and manage execution for a late-stage gene therapy program for the treatment of a devastating, lethal rare disease.  You will oversee upcoming marketing applications while managing one or more direct reports. This company offers a fun, collaborative culture, a generous PTO package, and excellent benefits.  Now is an exciting time to join this fast-paced, energetic, and rapidly growing company! 

Responsibilities:

  • Design creative regulatory strategy for the global development for a rare disease gene therapy program in Phase 3.
  • Oversee and manage preparation and submission of a BLA including development of timelines.
  • Lead transparent and proactive interactions with regulatory agencies globally.
  • Collaborate with regulatory-CMC, regulatory operations, and medical writing functions to ensure seamless integration of various components into submissions as well as high quality submissions per agreed to timelines.
  • Drive adherence to regulatory guidelines for development of gene therapy products.
  • Manage one or more direct reports.
  • Participate in regulatory intelligence activities; review draft regulatory guidelines and monitor trends. 

Knowledge and Skills:

  • BS in biochemistry, chemistry, biology or related pharmaceutical fields. Advanced degree (PhD, PharmD, MS) strongly preferred.
  • At least eight years of regulatory affairs experience in biotech or pharmaceuticals.
  • Strong experience in developing global regulatory strategies.
  • Experience with preparation of initial INDs, CTAs, BLAs, NDAs, and/or MAAs.
  • Must have experience working directly with the FDA and/or other health authorities.
  • Understanding of the development of advanced therapy/innovative biologics products a plus. Gene or cell therapy experience desired by not required.
  • Experience in rare disease/orphan drugs preferred but not required.
  • Excellent project management and writing skills, as well as a good understanding of the underlying science.
  • Knowledgeable in ICH, FDA and EMA guidelines
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Excellent communication skills and ability to influence across multiple functions

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