Director / Senior Director / Executive Director, Regulatory Affairs

About the role

The Director/Senior Director/Executive Director, Regulatory Affairs at Bridgene Bio Oncology Therapeutics (BBOT) leads regulatory strategy and submission execution for oncology development programs. This role requires a strategic thinker with deep knowledge of global regulatory requirements, a track record leading complex submissions and health authority interactions, and the ability to thrive in a fast-paced, small-company biotechnology environment.

Requirements

• Key Responsibilities:
  • Regulatory Submissions: Lead hands-on regulatory submission activities (Director), and provide strategic oversight of submissions led by direct reports and CRO partners (Senior Director/Executive Director).
  • Manage close communication with CROs to ensure on-time submissions and submission tracking.
  • Partner with Regulatory Operations and Medical Writing to ensure submissions meet global regulatory requirements and are delivered with high quality and on schedule.
  • Review key submission documents to ensure consistency of regulatory messaging.
• Regulatory Strategy: Lead/support development and execution of global regulatory strategies – including early-phase strategies for first-in-human through dose-expansion programs – to support efficient product development and registration. Provide strategic regulatory recommendations across nonclinical, CMC, clinical development, companion diagnostics, and lifecycle management activities. Ensure regulatory strategies are aligned with corporate objectives, development timelines, and commercialization plans. Evaluate regulatory risks and opportunities while recommending practical solutions to optimize development pathways, including expedited pathways (Breakthrough Therapy, Fast Track, Accelerated Approval) where applicable. Monitor evolving global regulatory requirements and communicate potential impact on company programs.
• Regulatory Leadership: Serve as the Regulatory Affairs representative on cross-functional program teams for the assigned program(s). Lead regulatory planning for major development milestones, including those relevant to public company disclosures and investor communications, in partnership with Legal and Investor Relations. Develop regulatory timelines and ensure alignment across functional teams. Provide strategic input into clinical protocols, investigator brochures, informed consent documents, safety reporting, and other development documents. (Senior Director/Executive Director) Manage and mentor regulatory affairs staff as team scope grows.
• Health Authority Interactions: Lead preparation for regulatory agency meetings, including Type B/C meetings characteristic of early-phase oncology programs. Lead or support interactions with FDA and other global health authorities for assigned programs. Lead development of briefing documents, regulatory correspondence, meeting requests, and responses to health authority questions. Ensure timely, accurate, and scientifically sound responses to regulatory agencies.

Qualifications

• Education: Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline. Advanced degree (PharmD, PhD, MS, or equivalent) preferred.
• Experience: Director: Approximately 10–12 years of regulatory affairs experience within biotechnology or pharmaceutical drug development, including direct experience in oncology drug development. Demonstrated experience leading regulatory submissions and strategy for oncology development programs, ideally spanning first-in-human through early efficacy stages. Experience serving as regulatory lead for FDA interactions and major regulatory submissions.
• Senior Director: Approximately 14+ years of progressive regulatory affairs experience, including oncology drug development. Demonstrated leadership of multiple development programs, and experience managing or mentoring regulatory staff.
• Executive Director: Approximately 18+ years of progressive regulatory affairs experience. Experience influencing portfolio-level regulatory strategy and managing/mentoring regulatory staff.
• Knowledge and Skills: Extensive knowledge of FDA, EMA, ICH, and other major global regulatory requirements. Strong understanding of oncology drug development from First-in-Human through commercialization. Experience with expedited regulatory pathways (Breakthrough Therapy, Fast Track, Accelerated Approval). Demonstrated experience leading: – INDs / CTAs – Marketing application submissions – Major amendments – Health authority meetings – Regulatory responses Strong understanding of global regulatory strategy, benefit-risk assessment, and regulatory precedent. Excellent written and verbal communication skills. Outstanding collaboration and influence skills across multidisciplinary teams. Ability to make strategic decisions in situations involving ambiguity and competing priorities. Strong organizational and project management capabilities.

Preferred Qualifications

• Experience in small or mid-sized biotechnology companies.
• Experience supporting global development programs.
• Experience working with companion diagnostics and precision medicine approaches.
• Experience supporting licensing, acquisitions, or due diligence activities.

What We Offer

Bridgene Bio Oncology Therapeutics (BBOT) strives to provide a market-competitive total rewards package, including base pay, annual performance bonus, company equity, and comprehensive health benefits. The final compensation package will depend on factors including experience, skills, education, location, and performance throughout the interview process. Salary Range: $210,000 - $275,000.