Director, Regulatory Affairs

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About the role

J ob Title: Director, Regulatory Affairs, Pharmaceuticals Employment Type: Permanent Location: 300 Welsh Road, Building 5, Suite 201, Horsham, PA 19044, USA A bout ClinChoice ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director, Regulatory Affairs (Hybrid) on a permanent basis. 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 am

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