Director, Regulatory Affairs

Socket.dev; Horsham (PA); Hybrid; USD 180,000 - 230,000; Full time

Job summary

ClinChoice is seeking a Director of Regulatory Affairs (Hybrid) in Horsham, PA. The role leads regulatory strategy for biopharma, directs cross‑functional teams, and ensures compliance with FDA and global authorities across INDs, CTAs, NDAs, MAAs, and BLAs.

The ideal candidate has 8+ years in Regulatory Affairs, strong leadership, and excellent communication skills to mentor staff and drive strategic initiatives in a fast-paced CRO environment.

Qualifications

• Bachelor’s degree in a scientific field; advanced degree preferred.
• Eight+ years in Regulatory Affairs for biopharmaceuticals; Phase 1–III experience desirable.
• Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs/BLAs with approvals.
• Direct experience with the FDA and other health authorities; global biologics experience desired.
• Strong knowledge of lifecycle Regulatory Affairs (Development, CMC, Labeling, Promotion...).
• Ability to interpret regulatory trends affecting business decisions.
• Initiate and support digital technology solutions for regulatory processes.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Provide strategic and tactical 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 government regulations, guidelines, and best practices.
• Devise and implement global regulatory strategy with leadership oversight for projects.
• Manage and prepare regulatory documents for submissions (INDs, CTAs, NDAs, MAAs, BLAs).
• Act as SME with deep knowledge of HA regulations across biopharmaceuticals.
• Collaborate to author and compile documents for regulatory submissions.
• Mentor internal team across regulatory projects.
• Monitor regulatory environment and communicate changes and impacts.
• Advise senior leadership on regulatory guideline impacts and opportunities.
• Hire, develop and mentor regulatory personnel and future staff.
• Prepare client presentations and support department growth activities.

Skills

Exceptional communicator

Leadership

Cross-functional collaboration

Strategic thinking

Go-getter mindset

Education

Bachelor’s degree in a scientific field

Advanced degree (PharmD/PhD/MS) preferred

Job description

Job 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

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.

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 personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.