Remote Executive Director | Global Regulatory Strategy

Erasca, Inc.; San Diego (CA); Hybrid; USD 275,000 - 355,000; Full time

Job summary

Erasca, Inc. is seeking an Executive Director or VP, Regulatory Affairs to lead global regulatory strategy from pre-IND through NDA and post‑approval.

You will manage interactions with the FDA and international health authorities, guide cross‑functional teams, and drive regulatory submissions for groundbreaking cancer therapies. The role offers hybrid work in San Diego, CA or South San Francisco, CA, or full remote work across the United States, with a competitive salary and bonus plan aligned

Qualifications

• 10+ years of relevant experience in pharma or biotech regulatory affairs.
• Deep expertise in global regulatory strategy from pre-IND through NDA and post-approval.
• Experience with US and EU regulatory affairs (IND, NDA, CTA, etc.) and interactions with health authorities.
• Experience with NDA submissions and product approvals preferred.
• Exposure to expedited programs (Fast Track, Breakthrough Therapy, PRIME) a plus.

Responsibilities

• Represent regulatory on program and study teams and in disease area strategy meetings.
• Develop regulatory strategies to ensure development plans meet regulatory requirements.
• Lead or support preparation and review of regulatory documents (IND, NDA, iPSP/PIP, DSUR, etc.).
• Act as Regulatory Affairs liaison in business development and due diligence activities.
• Review clinical documents for regulatory content and compliance.
• Plan and direct regulatory activities with regulatory staff and cross-functional teams.

Skills

Regulatory strategy

FDA liaison

Regulatory submissions

Leadership

Regulatory writing

Job description

Erasca, Inc. is seeking an Executive Director or VP, Regulatory Affairs to lead global regulatory strategy from pre-IND through NDA and post‑approval.

You will manage interactions with the FDA and international health authorities, guide cross‑functional teams, and drive regulatory submissions for groundbreaking cancer therapies. The role offers hybrid work in San Diego, CA or South San Francisco, CA, or full remote work across the United States, with a competitive salary and bonus plan aligned