Director - Regulatory Affairs

Director, Regulatory Affairs South San Francisco, CA | $270,000–$280,000

Bring your regulatory strategy expertise to a pioneering, research-driven biotechnology company where your work will have a direct impact on development programs, health authority interactions, and the path to approval. This is an opportunity to shape worldwide regulatory strategy for novel programs, including first-in-class programs where limited FDA guidance exists. You'll advise executive leadership and partner with clinical, CMC, commercial, and external collaborators in a collaborative, start-up style environment.

Why You'll Want to Join

• $270,000–$280,000 annual salary range, based on experience and qualifications
• Annual bonus eligibility
• Opportunity to join an innovative, science-first biotech organization
• Strategic ownership of global regulatory strategy from IND-enabling work through proof-of-concept and beyond
• Direct advisory role with executive leadership
• Exposure to first-in-class programs, partnered programs, and multiple indications
• Collaborative, mission-driven team environment

This position is based on-site in South San Francisco at least four days per week.

What You'll Do

• Develop and execute worldwide regulatory strategy for assigned programs, including first-in-class programs, partnered programs, and programs with multiple indications
• Advise executive leadership, clinical development, CMC, and commercial teams on trial design, surrogate endpoints, accelerated approval strategies, and risk mitigation
• Lead interactions with global health authorities and develop briefing packages for those engagements
• Oversee or directly manage the compilation, review, and submission of regulatory applications, ensuring accuracy, completeness, and timeliness
• Partner with CMC and CMC Regulatory to develop effective CMC regulatory strategies
• Represent Regulatory Affairs on development teams and help them interpret and apply regulations and guidance
• Provide strategic and compliance input on protocols, reports, and other source documents
• Monitor global regulatory developments, brief senior leadership, and build proactive strategies for anticipated changes
• Collaborate with cross-functional teams, full-time staff, and independent consultants as needed

What You'll Bring

Required:

• Master's degree in a life science discipline from an accredited college or university
• 10+ years of regulatory affairs experience in an industry, academia, or clinical research organization setting
• Direct experience authoring and managing (or overseeing others on) substantial regulatory submissions, including INDs/CTAs
• Strong knowledge of global regulations, including FDA and EMA
• Experience with mechanisms to expedite agency interactions
• Advanced skill in developing regulatory path proposals, guiding development teams based on ongoing regulatory outcomes, and leading well-prepared health authority interactions
• Excellent communication skills and the ability to influence stakeholders internally and externally
• Strategic, self-motivated problem solver with exceptional organizational skills and the ability to work independently or collaboratively in a fast-paced, start-up environment
• Willingness to work on-site at least four days per week

Especially Helpful:

• A PhD is preferred.
• Rare disease development and/or novel endpoint experience is highly valued, as is a proven track record developing and executing biotech regulatory submissions, including at least one major application and approval (NDA, BLA, MAA).
• Experience with successful NDA/BLA/MAA filings is highly desirable.