Executive Director/VP, Regulatory Affairs

Erasca, Inc.

. Lead regulatory strategy for a defined disease area .

Posted 10/22/2026full-timeSan Diego • California • United StatesLead💰 $275,000 - $355,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global regulatory strategy, including the development and execution of regulatory submissions from pre-IND through NDA and post-approval. Proven ability to lead cross-functional teams and effectively communicate with health authorities while ensuring compliance with US and EU regulations.

Highest-signal resume keywords

Global Regulatory StrategyRegulatory Submissions (IND, NDA, CTA)FDA and ICH Guidelines KnowledgeLeadership and MentoringRegulatory Compliance and Audits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Document PreparationRegulatory Submission OversightClinical Document ReviewRegulatory Milestone ManagementProduct Lifecycle ManagementRegulatory Affairs Efficiency ImprovementNDA Submission ExperienceExpedited Programs KnowledgeDeep Expertise in Pharma/Biotech Regulatory Affairs

Soft Skills

Strong Organizational SkillsEffective Communication SkillsInterpersonal SkillsCollaborative Team PlayerProblem-Solving Skills

Industry Keywords

PharmaBiotechRegulatory AffairsFDAEU RegulationsINDNDACTAFastTrackBreakthrough Therapy Designation

About the role

Key responsibilities & impact

Lead regulatory strategy for a defined disease area
Develop and execute global regulatory strategies and submissions from pre-IND through regulatory approval, launch, commercialization, and product lifecycle management
Represent Regulatory Affairs on program and study teams and disease area strategy and planning meetings
Develop regulatory strategies ensuring 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
Oversee regulatory 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 primary liaison with the FDA and OUS health authorities
Facilitate timely review and approval of regulatory submissions and lead regulatory milestone discussions
Plan and direct regulatory activities through regulatory staff and cross-functional teams
Provide regulatory support for company compliance initiatives, audits, and inspections
Oversee service providers and regulatory consultants
Lead and support development of systems and processes to improve Regulatory Affairs efficiency
Keep current on US and OUS regulations applicable to company products and processes
Report to the Chief Regulatory Affairs Officer

Requirements

What you’ll need

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, including IND, CTA, CTN, and NDA
Experience leading formal interactions with health authorities, including pre-IND, End-of-Phase, and Scientific Advice
Proven knowledge of FDA and ICH guidelines
Ability to translate regulatory requirements into practical workable plans
Strong organizational skills and excellent attention to detail
Effective interpersonal, communication, influencing, and writing skills
Experience leading, mentoring, and developing direct reports
Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment
Collaborative team player with a can-do attitude and ability to identify and implement creative solutions to complex problems
Strong learning orientation, curiosity, and commitment to science and patients
Experience with NDA submission and product approval preferred
Experience with expedited programs such as FastTrack, Breakthrough Therapy Designation, and PRIME is a plus

Benefits

Comp & perks

Annual bonus
Equity grant at hire and annually in the form of an option to purchase stock in the future for a specified price
Paid Time Off
Holiday and Sick Leave
Medical, Dental and Vision Plans
Short- and Long-Term Disability
Basic and Voluntary Life/AD&D Coverage
Flexible Spending Accounts (FSA, HSA, and Commute)
Critical Illness and Accident Coverage
Pet Insurance
Employee Assistance Program
401(k) Plan with Erasca contribution
Employee Stock Purchase Program
Casual, collaborative, and fun work environment