Director, Regulatory Affairs

ClinChoiceUnited StateshybridSalary not postedView the original posting at ClinChoice ↗

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 ambiguity in a small, fast-paced environment. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first s

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