Remote opportunity at
Erasca, Inc.Exec Director/VP Regulatory Affairs
Erasca, Inc. is a clinical-stage precision oncology organization dedicated to discovering, developing, and delivering cancer medicines. The company focuses on blocking the RAS/MAPK signaling pathway, which…
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About This Role
Erasca, Inc. is a clinical-stage precision oncology organization dedicated to discovering, developing, and delivering cancer medicines. The company focuses on blocking the RAS/MAPK signaling pathway, which is involved in millions of cancer cases annually. Erasca is currently hiring for an Executive Director or Vice President of Regulatory Affairs to direct regulatory strategies for a designated disease portfolio. Reporting directly to the Chief Regulatory Affairs Officer, the hired professional will shape…
Job Description
Erasca, Inc. is a clinical-stage precision oncology organization dedicated to discovering, developing, and delivering cancer medicines. The company focuses on blocking the RAS/MAPK signaling pathway, which is involved in millions of cancer cases annually. Erasca is currently hiring for an Executive Director or Vice President of Regulatory Affairs to direct regulatory strategies for a designated disease portfolio.
Reporting directly to the Chief Regulatory Affairs Officer, the hired professional will shape global regulatory planning and submissions spanning from pre-IND stages through commercial approval, launch, and ongoing product lifecycle management. This position can operate on a hybrid schedule out of San Diego or South San Francisco, California, or can be performed fully remote from any location across the United States.
The role involves serving as the regulatory representative on study teams, guiding interactions with the FDA and international health authorities, and overseeing submissions such as INDs and NDAs. The successful candidate will also manage regulatory staff, provide guidance for company compliance initiatives, and collaborate with business development teams.
Responsibilities
- Represent regulatory affairs on program teams and during disease area strategy sessions
- Formulate global regulatory strategies to guarantee development plans align with health authority requirements
- Lead or assist in preparing and reviewing regulatory submissions including INDs, IMPDs, DSURs, briefing packages, and NDAs
- Serve as the primary point of contact for the FDA and international health authorities
- Direct regulatory activities through internal staff and cross-functional teams
- Provide regulatory oversight for service providers, consultants, and corporate compliance initiatives
Requirements
- Undergraduate degree
- 10 or more years of relevant regulatory affairs experience within the pharmaceutical or biotechnology sectors
- Direct expertise in global regulatory strategy spanning from pre-IND to post-approval phases
- Demonstrated knowledge and experience with US and EU regulatory frameworks and health authority interactions
- Strong proficiency in FDA and ICH guidelines
- Proven track record of leading, mentoring, and developing direct reports
Qualifications
- Advanced degree
- Experience with NDA submissions and product approvals
- Familiarity with expedited programs for serious conditions such as Fast Track, Breakthrough Therapy Designation, or PRIME
Core Skills
Benefits
- Annual bonus eligibility
- Initial and annual equity grants in the form of stock options
- Paid time off, holidays, and sick leave
- Medical, dental, and vision insurance plans
- Short-term and long-term disability coverage
- Basic and voluntary life and accidental death and dismemberment coverage
- Flexible spending accounts for medical, health savings, and commuter expenses
- Critical illness and accident coverage
- Pet insurance
- Employee assistance program
- 401(k) plan with company contributions
- Participation in an employee stock purchase program
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Where is this position located?
This position offers a hybrid schedule based out of San Diego, California or South San Francisco, California, or it can be performed fully remote from anywhere in the United States.
What is the expected salary range for this role?
The anticipated salary range is between $275,000 and $355,000, with the final offer dependent on factors such as industry experience and education.
What education and experience are required?
Candidates must hold an undergraduate degree and have at least 10 years of relevant regulatory affairs experience in pharma or biotech, including expertise in global regulatory strategy from pre-IND through NDA and post-approval.
Sample Interview Questions
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