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.