Director, Regulatory Affairs

ClinChoice; United States; Híbrido; USD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

ClinChoice is seeking a Director of Regulatory Affairs for Pharmaceuticals and Biotech. This hybrid, permanent role leads regulatory strategy and execution for North America and collaborates with cross-functional teams to ensure timely submissions and global compliance.

The candidate will have extensive FDA experience, develop regulatory strategies for INDs/NDAs/MAAs, mentor teams, and drive process improvements within a fast-paced CRO environment.

Formación

• Eight or more years in Regulatory Affairs for biopharmaceutical products.
• Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs.
• Direct experience working with the FDA and health authorities.
• Strong knowledge of regulatory lifecycle across development, CMC, labeling, promotion, commercialization.

Responsabilidades

• 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.
• Collaborate globally to devise and implement regulatory strategy for client projects.
• Oversee preparation of regulatory documents and submissions (INDs, CTAs, NDAs, MAAs, BLAs).
• Mentor internal team across regulatory projects.

Conocimientos

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional leadership

IND/CTA/NDAs

Educación

Bachelor in Science

PharmD/PhD preferred

Descripción del empleo

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.

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 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.