Director, Regulatory Affairs New

ClinChoice; Horsham, Northern (PA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

ClinChoice is seeking a Director, Regulatory Affairs (Hybrid) to lead regulatory strategy for North American biopharma programs from our Horsham, PA office. You will drive strategic leadership, oversee submissions, and collaborate with cross-functional teams to ensure compliant, timely INDs, CTAs, NDAs, MAAs, and BLAs.

The role demands deep knowledge of FDA processes, global biologics experience, and a hands-on, entrepreneurial approach to guide projects through development, registration, and

Qualifications

• Bachelor’s degree in a scientific field required; advanced degree preferred (PharmD/PhD/MS).
• Eight or more years of Regulatory Affairs experience in biopharmaceuticals, with Phase 1–III exposure.
• Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with approvals.
• Direct experience with the FDA and other health authorities; global biologics exposure desired.
• Strong knowledge of lifecycle regulatory affairs across development, CMC, labeling, promotion, and operations.
• Ability to interpret regulatory trends affecting business decisions and manage cross-functional teams.
• Experience mentoring regulatory staff and leading strategic regulatory projects.

Responsibilities

• Provide strategic and tactical leadership of the regulatory affairs function in North America with cross-functional teams.
• 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 and provide leadership oversight for client projects.
• Manage, oversee and prepare regulatory documents and submissions per client requirements.
• Collaborate with internal staff to author and compile documents for submissions (INDs, CTAs, BLAs, NDAs, MAAs).
• Mentor internal regulatory staff and monitor regulatory developments.
• Communicate impacts of guidelines and policies to senior leadership; identify business opportunities.
• Hire, develop and mentor regulatory personnel.
• Prepare client presentations and support department growth activities.

Skills

Regulatory leadership

Regulatory project management

Cross-functional collaboration

INDs/CTAs/NDAs/MAAs/BLAs submissions

FDA/health authorities experience

Education

Bachelor's degree in 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

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.