Senior Vice President, Regulatory Affairs

Senior Vice President, Regulatory Affairs

About the Company

Innovative clinical-stage biotechnology firm developing gene therapies

Industry

Biotechnology

Type

Public Company

Founded

2015

Employees

201-500

Categories

• Biotechnology
• Health Care
• Pharmaceutical

Specialties

About the Role

The Company is seeking a Senior Vice President for Regulatory Affairs to join their dynamic team. The successful candidate will be a key member of the senior leadership, responsible for developing and driving regulatory strategies for the company's innovative gene therapy pipeline. This pivotal role involves leading regulatory interactions with health authorities, advising the leadership team on regulatory strategy, and ensuring compliance with global regulations. The ideal candidate will have a strong background in the biopharmaceutical industry, with a focus on gene therapy and a proven track record of successful regulatory submissions, including accelerated approvals. They should be adept at managing a high-quality regulatory team, fostering relationships with regulatory agencies, and contributing to the strategic direction of the organization. Applicants for the SVP, Regulatory Affairs position at the company should hold an advanced degree in a relevant scientific area and have 10-15 years' of biopharmaceutical leadership experience in regulatory affairs. A deep understanding of regulatory requirements for gene therapy products, including experience with INDs, CTAs, BLAs, and MAAs, is essential. The role requires a leader with a passion for regulatory affairs, science, and making a difference in patients' lives, particularly those affected by rare diseases. The candidate should be a strategic thinker, capable of anticipating and defining the future of regulatory pathways, and be a collaborative influencer with a strong network of relationships. Experience with Orphan Drug, Breakthrough, and Accelerated Approval designations, as well as a significant level of interaction with the FDA, EMA, and other regulatory agencies, is highly valued.

Hiring Manager Title

Chief Medical Officer

Travel Percent

Less than 10%

Functions