Head of Regulatory

EPM Scientific; San Mateo (CA); Hybrid; USD 260,000 - 420,000; Full time

Job summary

EPM Scientific is seeking a Head of Regulatory Affairs (Senior Director/VP) based in San Mateo, CA with hybrid work requiring 3 days in-office. You will lead US regulatory strategy, serve as the FDA main contact, and guide late-stage and approved programs, shaping submission documents and overall regulatory direction.

You will work closely with cross-functional teams to prepare NDAs/INDs, coordinate meetings, and drive orphan designation efforts, reporting to the CEO/CSO in a small, hands-on

Qualifications

• Advanced degree in life sciences required.
• 15+ years of regulatory affairs experience in biotech/pharma.
• Hands-on experience writing clinical and nonclinical regulatory documents.

Responsibilities

• Develop and lead US regulatory strategy for development and approved programs.
• Serve as the main point of contact with FDA, including preparing for and leading agency meetings (Type A/B/C, pre-NDA).
• Write and review the main clinical and nonclinical submission sections, including CTD Modules 2.4-2.7.
• Prepare FDA briefing packages, meeting requests and responses to agency questions.
• Lead preparation and submission of NDAs, INDs, supplements and amendments in eCTD format.
• Lead Orphan Drug Designations and other expedited pathway requests.
• Work with the clinical, nonclinical, CMC and biostatistics teams to support submissions.
• Keep up to date on FDA regulations, ICH guidelines and industry developments.
• Maintain organized regulatory records and correspondence.

Skills

Regulatory strategy

FDA meetings leadership

Scientific writing

Cross-functional collaboration

Attention to detail

Education

PhD/PharmD/MSc in life sciences

Job description

Head of Regulatory Affairs (Senior Director/VP) Location: San Mateo, CA (Hybrid, 3 days a week in office)

About the Company

My client is a specialty biotech company with an approved rare disease product and an active Phase 3 program. The company handles regulatory strategy and writing in-house, which gives this role broad ownership and direct involvement across programs.

About the Role

The Head of Regulatory Affairs will lead US regulatory strategy and serve as the main point of contact with the FDA. Reporting to the CEO and CSO, this person will guide regulatory direction for late-stage and approved programs and contribute directly to key submission documents.

Key Responsibilities

• Develop and lead US regulatory strategy for development and approved programs
• Serve as the main point of contact with FDA, including preparing for and leading agency meetings (Type A/B/C, pre-NDA)
• Write and review the main clinical and nonclinical submission sections, including CTD Modules 2.4-2.7
• Prepare FDA briefing packages, meeting requests and responses to agency questions
• Lead preparation and submission of NDAs, INDs, supplements and amendments in eCTD format
• Lead Orphan Drug Designations and other expedited pathway requests
• Work with the clinical, nonclinical, CMC and biostatistics teams to support submissions
• Keep up to date on FDA regulations, ICH guidelines and industry developments
• Maintain organized regulatory records and correspondence

Qualifications

• Advanced degree (PhD, PharmD or MSc) in a life sciences field
• 15+ years of regulatory affairs experience in biotech or pharma
• Experience leading FDA meetings and contributing to product approvals
• Hands-on experience writing clinical and nonclinical regulatory documents
• Experience with NDAs, INDs and Orphan Drug Designations
• Strong scientific writing, communication and organizational skills
• Comfortable working in a hands-on role on a small team
• Based in the Bay Area or open to relocating within California

What's Offered

• Direct reporting line to the CEO and CSO
• Broad ownership of regulatory strategy across approved and late-stage programs
• The chance to shape and build the regulatory function
• Competitive salary, bonus and benefits