Director, Regulatory Affairs

📋 Description

• Provide strategic and tactical leadership of the regulatory affairs function in North America, in
• Lead client interactions and act as Subject Matter Expert on Regulatory projects for the biopharma
• Ensure compliance with all appropriate government regulations, industry guidelines, and best
• In collaboration with regulatory colleagues globally, devise and implement global regulatory
• Manage, oversee and/or prepare regulatory documents and submissions in accordance with clients’
• Act as SME with deep knowledge of HA regulations for all aspects of biopharmaceutical regulations.

🎯 Requirements

• Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
• Eight or more years of experience in Regulatory Affairs for biopharmaceutical products (small &amp
• Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with a track
• Direct experience working with the FDA and other health authorities; experience with CBER and
• Strong knowledge of Regulatory Affairs throughout the product lifecycle, including Development
• Must be able to assimilate and interpret trends in the life sciences regulatory environment that