Director, Regulatory Affairs

ClinChoice•Horsham, PA

6d•Hybrid

About The Position

ClinChoice is looking for a dynamic person to join their in-house team as a Director, Regulatory Affairs (Hybrid) on a permanent basis. This role involves formulating and implementing 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.

Requirements

Bachelor’s degree in a scientific field.
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.
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.

Nice To Haves

Advanced degree, such as PharmD, PhD, MS preferred.
Experience with CBER and global biologics experience highly desired.

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.