Job Description

Head of Regulatory Affairs (Director / Senior Director)

Location: San Francisco Bay Area (Hybrid - 3 days onsite)

Compensation: $200,000 - 285,000 base + bonus + equity

About the Role

A fast‑growing biotechnology company developing treatments for patients with underserved, high‑need conditions is seeking a Head of Regulatory Affairs. This person will serve as the lead regulatory voice for the organization, shaping global regulatory strategy and driving the preparation, submission, and approval of key regulatory filings.

This role is ideal for a hands‑on, experienced regulatory leader who combines strategic vision, operational rigor, and the ability to successfully interact with FDA and global health authorities. You will guide programs through early‑stage development, late‑stage milestones, and lifecycle management, and play a central role in bringing transformative therapies to patients.

Key Responsibilities

Regulatory Strategy & Leadership

• Serve as the Head of Regulatory Affairs, leading all U.S. and global regulatory activities for clinical‑stage and commercial programs.
• Develop and execute comprehensive regulatory strategies from pre‑IND through NDA/BLA/MAA submissions, approvals, and post‑marketing commitments.
• Provide expert regulatory insight to executive leadership, program teams, and cross‑functional stakeholders.

FDA & Global Health Authority Interactions

• Lead FDA meetings (pre‑IND, Type B/C, pre‑NDA, labeling, and post‑marketing), including meeting strategy, briefing package authorship, team preparation, and real‑time negotiation.
• Act as the primary point of contact for FDA, EMA, MHRA, Health Canada, PMDA, and other regulatory agencies.

Submission Leadership

• Author, review, and oversee high‑quality regulatory submissions, including:
• INDs, CTAs, IMPDs
• NDAs/BLAs/MAAs
• Amendments, supplements, safety updates, and lifecycle submissions
• Ensure all submissions are compliant with regulatory standards, data‑driven, and aligned with program objectives

Cross‑Functional Collaboration

• Partner with Clinical, CMC, Nonclinical, Biostatistics, Quality, and Program Management to ensure integrated development plans and submission readiness.
• Guide teams through regulatory expectations and risk‑mitigation strategies.

Late‑Stage Development & Commercial Support

• Lead regulatory strategy for Phase 2/3 registration studies, labeling discussions, and preparation for potential advisory committee engagements.
• Oversee post‑marketing strategy, including supplements, variations, facility changes, safety reporting, and global lifecycle management.

Qualifications

Required

• 12+ years of Regulatory Affairs experience in the biopharmaceutical industry; at least 5 years in a senior/lead regulatory role.
• Direct experience leading FDA interactions and serving as the primary regulatory representative in agency meetings.
• Hands‑on leadership of IND and NDA/BLA submissions, including at least one product approval (or major contribution to approval).
• Experience developing regulatory strategy for complex or specialty products (e.g., biologics, peptides, gene/cell therapy, rare disease, ophthalmology, dermatology, or endocrine).
• Strong understanding of global regulatory frameworks (FDA, EMA, MHRA, PMDA, Health Canada).
• Excellent communication skills; able to influence, negotiate, and communicate effectively at all levels.

Preferred

• Experience in rare disease, first‑in‑human programs, expedited pathways (Fast Track, Breakthrough, Priority Review).
• Prior experience leading submissions for small, lean biotech organizations.
• Advanced scientific degree (PhD, PharmD, MS, etc.).

Job Tags

Similar Jobs