VP, Regulatory Affairs

A leading biotechnology company specializing in advanced cell and gene therapies is seeking a highly experienced and strategic leader to drive regulatory initiatives within their organization. The company is currently conducting a pivotal Phase 3 clinical trial for a groundbreaking therapeutic product. The organization is headquartered in the greater Philadelphia area.

Role Overview:

The Vice President of Regulatory Affairs will be responsible for shaping the regulatory strategy for a cutting-edge therapeutic product, guiding it from early development stages to global registration and lifecycle management. The ideal candidate will lead and support internal and external teams to ensure successful regulatory submissions and meet industry standards.

Key Responsibilities:

• Develop and implement regulatory strategies to support product programs from early development through global registration and lifecycle management.
• Communicate regulatory requirements clearly and effectively to both internal teams and external partners.
• Evaluate proposed manufacturing changes, providing strategic guidance to ensure optimal implementation.
• Lead the development and submission of CMC (Chemistry, Manufacturing, and Controls) elements for clinical trial and marketing applications.
• Ensure regulatory submissions are high-quality, consistent, and meet all necessary regulatory standards.
• Provide expert advice to senior management and staff on regulatory timelines, strategy, and commercialization goals.
• Liaise with external partners, including contract manufacturers and other business partners.
• Act as a liaison with FDA and other global regulatory agencies, attending meetings as needed.
• Keep the company informed of the latest regulatory changes and ensure compliance with all applicable regulations.
• Monitor and advise on the impact of new and evolving regulatory requirements and procedures.

Qualifications:

• A Bachelor’s degree in Chemistry, Biological Sciences, or a related field is required; advanced degrees and experience with CMC are preferred.
• Minimum of 15 years of experience in Regulatory Affairs, with a focus on cell and gene therapy development and approval.
• Strong knowledge of relevant regulations for cell and gene therapy.
• Proven organizational and leadership skills, with the ability to manage cross-functional teams in a matrixed environment.
• Ability to prioritize and manage multiple projects under strict deadlines.
• Strong communication skills, both written and verbal.