Head of Regulatory Affairs: US Strategy & FDA Leadership

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

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