Executive Director or VP, Regulatory Affairs

Reporting to the Chief Regulatory Affairs Officer, the Executive Director or VP, Regulatory Affairs will lead regulatory strategy for a defined disease area and develop and execute global regulatory strategies and submissions from pre-IND through regulatory approval to launch, commercialization, and product lifecycle management.

The position can be hybrid in San Diego, CA or South San Francisco, CA or fully remote anywhere in the United States.

Essential Duties and Responsibilities:

• Represent regulatory affairs on program and study teams and in disease area strategy and planning meetings
• Develop regulatory strategies with the team to ensure development plans are comprehensive and comply with regulatory requirements
• Lead or support preparation and review of regulatory documents (e.g., IND, CTA/IMPD, DSUR, pre-meeting briefing document, iPSP/PIP, NDA, sNDA), including oversight of regulatory submissions to assure technical accuracy and completeness
• Act as Regulatory Affairs representative in business development and due diligence activities
• Review relevant clinical documents for scientific content and regulatory compliance
• Act as primary liaison with the FDA and overseas health authorities to facilitate timely review and approval of regulatory submissions and lead regulatory milestone discussions (e.g., pre-IND, End-of-Phase, pre-NDA meetings, EU Scientific Advice)
• Plan and direct regulatory activities through regulatory staff and cross-functional teams
• Provide regulatory support for company compliance initiatives
• Regulatory support and guidance for regulatory audits and/or inspections
• Regulatory oversight of service providers and regulatory consultants
• Lead and support continued development of new systems and processes to improve efficiency for the regulatory department in a growing organization
• Keep current on US and overseas regulations that apply to company products and processes
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations

Required Education and Experience:

• Undergraduate degree required; advanced degree preferred
• 10+ years of relevant experience in pharma or biotech regulatory affairs required, including deep expertise in global regulatory strategy from pre-IND through NDA and post-approval
• Proven knowledge and experience in US and EU regulatory affairs required (e.g., IND, CTA, CTN, NDA) and leading formal interactions with health authorities (e.g., pre-IND, End-of-Phase, Scientific Advice, etc.)
• Experience with NDA submission and product approval preferred
• Experience with expedited programs for serious conditions such as FastTrack, Breakthrough Therapy Designation, PRIME, a plus
• Proven knowledge of FDA and ICH guidelines
• Ability to translate regulatory requirements into practical, workable plans
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail
• Effective interpersonal, communication, and influencing skills, including excellent writing skills
• Experience leading, mentoring, and developing direct reports
• Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems
• Strong learning orientation, curiosity, and commitment to science and patients