Vice President, Regulatory Affairs

Vice President, Regulatory Affairs

About the Company

Thriving T-cell receptor biotechnology company

Industry

Biotechnology

Type

Public Company

Founded

2008

Employees

201-500

Categories

• Biotechnology
• B2B
• Health Care
• Medical
• Pharmaceutical
• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• Academic Research
• Laboratory Services

Specialties

About the Role

The Company is seeking a Vice President of Regulatory Affairs to lead a team in the development and execution of scientific and tactical regulatory strategies, submissions, approvals, and compliance throughout the drug development process. The successful candidate will be responsible for ensuring the team's consistent, efficient, and timely document development, as well as overseeing interactions with regulatory agencies. Key responsibilities include collaborating with global regulatory leads, aligning regulatory goals with business objectives, and providing strategic guidance on labeling, risk management, and post-marketing requirements. The role demands a proven track record in all stages of drug development, experience in scientific regulatory strategy, and a strong background in managing regulatory submissions globally. Candidates for the Vice President of Regulatory Affairs position at the company should have 15-20+ years' of experience in regulatory affairs within a biopharmaceutical organization, with a focus on biologics drug development. The ideal candidate will have a background in oncology, anti-infectives, or autoimmune disease, and must have led the preparation, submission, and approval of at least one NME. A strong educational background in a scientific discipline is required, with an advanced degree being desirable. The role also requires excellent communication skills, the ability to influence and gain credibility with stakeholders, and a proven track record of success in regulatory affairs. The candidate should be adept at managing a team, be flexible, and comfortable with ambiguity in a fast-paced, innovative environment.

Hiring Manager Title

Senior Vice President of Regulatory Sciences

Travel Percent

Less than 10%

Functions