Director, Regulatory Affairs

clinchoice; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

ClinChoice is a global full-service CRO seeking a Director of Regulatory Affairs (Hybrid) to lead the regulatory function in North America and drive strategy for biopharma projects. The role emphasizes cross-functional collaboration, client interactions, and regulatory submissions across INDs, CTAs, NDAs, MAAs, and BLAs.

The successful candidate will have 8+ years in regulatory affairs for biopharma products, a scientific degree (advanced degrees preferred), and strong FDA experience.

Qualifications

• Bachelor’s degree in a scientific field; PharmD/PhD/MS preferred.
• Minimum eight years in Regulatory Affairs for biopharma products.
• Experience with INDs, CTAs, NDAs, MAAs, or BLAs and FDA interaction.

Responsibilities

• Provide strategic leadership of the regulatory affairs function in North America.
• Lead client interactions and act as SME on regulatory projects for biopharma clients.
• Ensure compliance with regulations and guidelines.
• Collaborate with global regulatory colleagues to devise and implement global regulatory strategy and provide leadership oversight for clients' projects.
• Mentor internal regulatory staff and monitor regulatory landscape.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Regulatory submissions

FDA experience

Education

Bachelor's degree in a scientific field

Advanced degree (PharmD/PhD/MS)

Job description

J ob Title: Director, Regulatory Affairs, Pharmaceuticals

Employment Type: Permanent

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

About 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 :

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.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified p