Snr Director of Global Regulatory Affairs
Edison-New Brunswick Metro Area, NJ
North American Lead Rare Disease: Senior Director, Global Regulatory Affairs
- Responsible for the development of US regulatory strategy to advance portfolio of development pipeline candidates and life cycle management of marketed products.
- Provide strategic input and ensure operational execution of US submission activities for the rare disease portfolio.
- Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for assigned projects which adhere to US regulatory and company guidelines.
- Have an understanding of the competitive environment of assigned products and developing US regulatory strategies that are differentiated and provide value for the patient
- Represent the North America Global Regulatory perspective as a member of project specific cross functional global regulatory team and be accountable to develop and maintain US aspects of regulatory strategy documents
- Lead the strategic development of briefing materials and prepare teams for US FDA meetings
- Accountable to define document content/strategy to align with US regulator expectations
- Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs.
BS degree in a relevant scientific discipline. Advanced degree is preferred (MS/PhD/PharmD)
10-15 years industry experience, with at least 6-9years working in regulatory affairs (US or globally).
Delivery of a number of major applications (NDA/BLA/IND)
Experience with late stage development/marketed products
Prior experience in the rare disease, rare blood disorders, or immunology therapeutic areas