Vice President, Regulatory Affairs

Vice President, Regulatory Affairs

About the Company

Well-funded clinical-stage biotechnology company with a broad, multi-asset pipeline.

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is seeking a Vice President of Regulatory Affairs to take on a pivotal role in the global regulatory strategy for late-stage assets. The successful candidate will be responsible for owning the strategy from pivotal trial design through to NDA/BLA submission and approval, and will serve as the primary point of contact with health authorities, particularly the FDA. This role requires a leader who can guide registration pathways across various indications and modalities, and who is adept at partnering with cross-functional teams to ensure regulatory strategy aligns with development timelines. The VP will also be expected to advise executive leadership on regulatory risks and pathway options as the portfolio evolves. Applicants for the VP of Regulatory Affairs position at the company should have a minimum of 10 years' experience in regulatory affairs within the biotech or pharma industry, with a focus on late-stage/registrational programs. Direct experience in leading FDA interactions and a background in oncology, immunology, neuroscience, rare disease, or other specialty areas is highly valued. The role offers the opportunity to work fully remote, with occasional travel for key meetings, and is ideal for a candidate who is looking for a high-visibility, strategic role with genuine executive visibility and the ability to shape the company's approach to regulatory filings.

Hiring Manager Title
Chief Medical Officer

Functions

• Business Development