Director, Regulatory Affairs

DUTIES & RESPONSIBILITIES:

As the Director of Regulatory Affairs for Pharmaceuticals & Biotech, you will have the opportunity to formulate and implement strategies to support multiple leading clients for various regulatory activities. The ideal candidate is a go-getter, exceptional communicator, and strategic thinker who thrives in a fast-paced environment with multiple demands and quickly becomes a trusted partner to their peers and clients alike.

Key Responsibilities:

• Provide strategic and tactical leadership of the regulatory affairs function in North America, in close collaboration with cross functional teams.
• Lead client interactions and act as Subject Matter Expert on Regulatory projects for the biopharma clients.
• Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
• In collaboration with regulatory colleagues globally, devise and implement global regulatory strategy and provide leadership oversight for clients’ projects.
• Manage, oversee and/or prepare regulatory documents and submissions in accordance with clients’ requirements.
• Act as SME with deep knowledge of HA regulations for all aspects of biopharmaceutical regulations.
• Collaborate with internal staff to author and compile documents for submission to regulatory agencies, including INDs, CTAs, BLAs, MAAs, and NDAs.
• Mentor internal team across various regulatory projects.
• Monitor Regulatory environment and communicate any changes and impact assessments to all team members.
• Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.
• Hire, develop and mentor regulatory personnel and future regulatory staff.
• Prepare client presentations & support department growth related activities, as needed.

Experience & Qualifications:

• 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 & large molecule, drug-device combination, vaccines, etc.), experience with Phase 1 through Phase III products is highly desirable.
• Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with a track record of successful approvals.
• Direct experience working with the FDA and other health authorities. Experience with CBER and global biologics experience highly desired.
• Strong knowledge of the industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
• Must be able to assimilate and interpret trends in the life sciences regulatory environment that directly affect business decisions in the industry.
• Initiate and support development of digital technology solution for various processes across regulatory affairs/operations.
• Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
• Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
• Must be comfortable with ambiguity in a small, fast-paced environment.