Exec Director/VP Regulatory Affairs

Erasca•San Diego, CA

13d

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 leads regulatory strategy for a defined disease area and develops and executes global regulatory strategies and submissions from pre-IND through approval, launch, commercialization, and product lifecycle management. The role reports to the Chief Regulatory Affairs Officer and may be hybrid in San Diego or South San Francisco, California, or fully remote anywhere in the United States. The position represents Regulatory Affairs on program and study teams and in disease-area strategy and planning, develops regulatory strategies with cross-functional teams, and leads or supports regulatory documents and submissions. It serves as a primary liaison with the FDA and other health authorities, directs regulatory activities through staff and cross-functional teams, and provides regulatory support for compliance initiatives, audits, and inspections. The role also oversees service providers and consultants and helps develop systems and processes as the regulatory department grows. The successful candidate will bring substantial pharmaceutical or biotechnology regulatory experience, global regulatory strategy expertise, and experience with US and EU regulatory affairs and formal health-authority interactions. The anticipated salary range is $275,000 to $355,000. The successful applicant is also eligible for an annual bonus and equity grant. Erasca describes its work environment as casual, collaborative, and fun.

Requirements

Undergraduate degree required; advanced degree preferred.
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 matters.
Experience leading formal interactions with health authorities, such as pre-IND, End-of-Phase, and Scientific Advice meetings.
Proven knowledge of FDA and ICH guidelines.
Ability to translate regulatory requirements into practical, workable plans.
Strong organizational skills and ability to prioritize multiple tasks with excellent attention to detail.
Effective interpersonal, communication, and influencing skills, including excellent writing skills.
Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment.
Collaborative approach, can-do attitude, and ability to 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 ensure development plans are comprehensive and comply 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 documents; oversee submissions for technical accuracy and completeness.
Represent Regulatory Affairs in business development and due diligence activities.
Review clinical documents for scientific content and regulatory compliance.
Serve as the primary liaison with the FDA and OUS health authorities to facilitate timely review and approval of submissions, and lead regulatory milestone discussions such as 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 regulatory department efficiency.
Keep current on US and OUS regulations applicable to company products and processes.
Perform duties in accordance with company core values, policies, and applicable regulations.
Lead, mentor, and develop direct reports.

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.
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.