Executive Director, Regulatory Affairs, Cell Therapy

About the Company

Innovative biopharmaceutical company

Industry
Pharmaceuticals

Type
Privately Held

Founded
1998

Employees
201-500

Categories

• Biotechnology
• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products

About the Role

The Company is seeking an Executive Director, Regulatory Affairs, Cell Therapy, to join their innovative team. The successful candidate will be the strategic lead for regulatory affairs, managing the operational aspects of all regulatory submissions and representing regulatory expertise. This role is pivotal in providing regulatory leadership and strategy for cross-functional sub teams, advising on best practices, and ensuring compliance with US and international regulations. The Executive Director will also be responsible for the management and development of a team, defining regulatory strategy, and preparing US and global regulatory submissions for the company's CAR-T products.Applicants must have a Master's or Ph.D. in life sciences, biotechnology, or relevant pharmaceutical science, with a minimum of fifteen years of pharmaceutical experience, including ten years in regulatory affairs, and two to three years in commercial regulatory experience with biologics, preferably cell therapy products. The role requires extensive knowledge of US, EU, and ICH regulatory requirements, the ability to apply this knowledge strategically and operationally, and a proven track record in delivering regulatory submissions for marketing authorizations and clinical trial applications. The ideal candidate will possess strong leadership skills, including inclusive leadership, emotional intelligence, and strategic thinking, as well as the ability to manage and develop a team. Experience in oncology drug development is desirable, and the candidate should demonstrate strong analytical, decision-making, and problem-solving skills, along with the highest ethical standards.

Hiring Manager Title
SVP Clinical Operations

Travel Percent
Less than 10%

Functions

• CEO/President
• Non-Profit Management
• Strategy
• General Management
• Operations