Executive Director, Global Regulatory Affairs — Remote

OpenKrill; United States; Hybrid; USD 275,000 - 355,000; Full time

Benefits offered by this job

Annual bonus

Equity grant

401(k) plan with Erasca contribution

Medical, Dental and Vision plans

Paid time off

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. This role will manage submissions, liaise with FDA and international authorities, and guide regulatory strategy across disease areas.

Hybrid in CA or remote within the U.S. The ideal candidate has 10+ years of pharma/biotech regulatory affairs experience, with strong leadership, writing, and cross-functional collaboration skills.

Qualifications

• 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 required (e.g., IND, CTA, CTN, NDA) and leading formal interactions with health authorities (e.g., pre IND, End‑of‑Phase, Scientific Advice, etc)
• Experience with NDA submission and product approval preferred
• Experience with expedited programs for serious conditions such as FastTrack, Breakthrough Therapy Designation, PRIME, a plus
• Proven knowledge of FDA and ICH guidelines
• Ability to translate regulatory requirements into practical workable plans
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail
• Effective interpersonal, communication and influencing skills, including excellent writing skills
• Experience leading, mentoring, and developing direct reports
• Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.
• Strong learning orientation, curiosity, and commitment to science and patients

Responsibilities

• Represent regulatory on program and study teams and in disease area strategy and planning meetings
• Working with the team, develop regulatory strategies to ensure development plans are comprehensive and comply with regulatory requirements
• Lead or support preparation and review of regulatory documents (e.g., IND, CTA/IMPD, DSUR, pre-meeting briefing document, iPSP/PIP, NDA, sNDA), including oversight of regulatory submissions to assure technical accuracy and completeness
• Act as Regulatory Affairs representative in business development and due diligence activities
• Review relevant clinical documents for scientific content and regulatory compliance
• Act as primary liaison with the FDA and OUS health authorities to facilitate timely review and approval of regulatory submissions and lead regulatory milestone discussions (e.g., pre-IND, End-of-Phase, pre-NDA meetings, EU Scientific Advice)
• Plan and direct regulatory activities through regulatory staff and cross functional teams
• Provide regulatory support for company compliance initiatives
• Regulatory support and guidance for regulatory audits and/or inspections
• Regulatory oversight of service providers and regulatory consultants
• Lead and support continued development of new systems and processes to improve efficiency for the regulatory department in a growing organization
• Keep current on US and OUS regulations that apply to company products and processes
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Skills

Regulatory strategy

Global regulatory affairs

FDA liaison

Regulatory submissions

Milestone discussions

Mentoring

Leadership

Writing skills

Interpersonal skills

Problem solving

Education

Undergraduate degree

Advanced degree preferred

Tools

IND

CTA/IMPD

DSUR

pre-meeting briefing document

iPSP/PIP

NDA

sNDA

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. This role will manage submissions, liaise with FDA and international authorities, and guide regulatory strategy across disease areas.

Hybrid in CA or remote within the U.S. The ideal candidate has 10+ years of pharma/biotech regulatory affairs experience, with strong leadership, writing, and cross-functional collaboration skills.