Exec Director/VP Regulatory Affairs
About The Position
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. 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, launch, commercialization, and product lifecycle management. The position reports to the Chief Regulatory Affairs Officer and may be hybrid in San Diego, California, or South San Francisco, California, or fully remote anywhere in the United States. The role represents Regulatory Affairs on program and study teams, supports disease-area strategy and planning, and leads or contributes to regulatory submissions and interactions with health authorities. It also provides regulatory guidance to cross-functional teams, supports compliance initiatives and audits, oversees service providers and consultants, and helps improve departmental systems and processes.
Requirements
- Undergraduate degree required.
- At least 10 years of relevant regulatory affairs experience in pharma or biotech, 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, including IND, CTA, CTN, and NDA work, and leading formal interactions with health authorities.
- Proven knowledge of FDA and ICH guidelines.
- Ability to translate regulatory requirements into practical, workable plans.
- Strong organizational skills, with the ability to prioritize multiple tasks and maintain excellent attention to detail.
- Effective interpersonal, communication, and influencing skills, including excellent writing skills.
- Experience leading, mentoring, and developing direct reports.
- Ability to achieve performance goals and meet deadlines in a fast-paced environment, collaborate as a team player, and identify and implement creative solutions to complex problems.
- Strong learning orientation, curiosity, and commitment to science and patients.
Nice To Haves
- Advanced degree.
- Experience with NDA submission and product approval.
- Experience with expedited programs for serious conditions, such as Fast Track, Breakthrough Therapy Designation, or PRIME.
Responsibilities
- Represent Regulatory Affairs on program and study teams and in disease-area strategy and planning meetings.
- Work with the team to develop regulatory strategies that make development plans comprehensive and compliant with regulatory requirements.
- Lead or support preparation and review of regulatory documents, including IND, CTA/IMPD, DSUR, pre-meeting briefing documents, iPSP/PIP, NDA, and sNDA submissions, and oversee submissions for technical accuracy and completeness.
- Represent Regulatory Affairs in business development and due diligence activities.
- Review relevant clinical documents for scientific content and regulatory compliance.
- Serve as the primary liaison with the FDA and non-US health authorities to facilitate timely review and approval of submissions.
- Lead regulatory milestone discussions, including pre-IND, End-of-Phase, pre-NDA, and EU Scientific Advice meetings.
- Plan and direct regulatory activities through regulatory staff and cross-functional teams.
- Provide regulatory support for company compliance initiatives, audits, and inspections.
- Oversee regulatory service providers and consultants.
- Lead and support development of systems and processes to improve efficiency in the growing regulatory department.
- Stay current on US and non-US regulations applicable to company products and processes.
- Perform duties in accordance with company core values, policies, and applicable regulations.
Benefits
- Paid time off, holiday, and sick leave.
- Medical, dental, and vision plans.
- Short- and long-term disability coverage.
- Basic and voluntary life and AD&D coverage.
- Flexible spending accounts, including FSA, HSA, and commute accounts.
- Critical illness and accident coverage.
- Pet insurance.
- Employee Assistance Program.
- 401(k) plan with Erasca contribution.
- Employee Stock Purchase Program participation.
- Annual bonus eligibility.
- Equity grant at hire and annually in the form of an option to purchase stock in the future for a specified price.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
