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 Senior Director or VP of Regulatory Affairs to take on a pivotal role in the expansion of its regulatory leadership team. The successful candidate will be responsible for owning the global regulatory strategy for late-stage assets, from the design of pivotal trials to the submission and approval of NDAs and BLAs. This role involves serving as the primary point of contact with the FDA and other health authorities, leading various meetings and negotiations, and guiding registration pathways across a range of indications and modalities. The ideal candidate will have a minimum of 10 years' experience in regulatory affairs within the biotech or pharma industry, with a focus on late-stage and registrational programs, and a proven track record of senior-level ownership. Applicants for this role at the company should be prepared to partner cross-functionally with clinical, CMC, safety, and quality teams to ensure that the regulatory strategy aligns with development timelines. The position requires the ability to advise executive leadership on regulatory risks and pathway options as the portfolio matures. The company is open to candidates from diverse therapeutic backgrounds, including oncology, immunology, neuroscience, rare disease, and other specialty areas. The role offers the opportunity for genuine strategic latitude, executive visibility, and a direct hand in shaping the company's approach to upcoming filings. The candidate should be comfortable with a fully remote work environment and be willing to travel periodically for key meetings or team collaboration.

Hiring Manager Title
Head of Regulatory Affairs

Functions

• Business Development