Director, Regulatory Affairs

Job Title: Director, Regulatory Affairs, Pharmaceuticals

Employment Type: Permanent

Location: 300 Welsh Road, Building 5, Suite 201, Horsham, PA 19044, USA

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.

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.

· 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.

• 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