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!
- 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