Vice President Regulatory Affairs

HW3; United States; On-site; USD 250,000 - 380,000; Full time

Job summary

Hw3 Llc is seeking a Vice President of Regulatory Affairs to lead global regulatory strategy and execution for biotech programs, spanning clinical development, submissions, and commercialization readiness.

The role emphasizes hands-on submission leadership, cross-functional collaboration, and mentoring Regulatory Affairs teams within a small biotech environment.

Qualifications

• 15+ years of Regulatory Affairs experience in biotech/pharma with leadership experience.

Responsibilities

• Lead global regulatory strategy across clinical development programs (early to late phase).
• Oversee regulatory submissions (IND, NDA, BLA, MAA) and regulatory approvals.
• Manage FDA, EMA and other global health authority interactions and meetings.
• Mentor and build Regulatory Affairs teams and collaborate with Clinical Development, CMC, Quality, and Commercial teams.

Skills

Regulatory leadership

Global strategy

IND/NDA submissions

FDA/EMA interactions

Team mentoring

Cross-functional leadership

Job description

Vice President, Regulatory Affairs | Biotech

We are hiring a Vice President of Regulatory Affairs on behalf of one of our small biotech clients.

In this role, you will lead global regulatory strategy and execution across clinical development programs, supporting late stage development, pivotal trials, regulatory submissions, and commercialization readiness.

Key Experience & Qualifications:

• 15+ years of Regulatory Affairs experience within biotech/pharma, including significant leadership experience.
• Experience in pulmonology, respiratory, and/or fibrotic diseases strongly preferred.
• Proven experience leading global regulatory strategy across early and late phase clinical development, particularly Phase 3 through registration.
• Significant experience leading IND, NDA, BLA, and/or MAA submissions, including successful regulatory approvals.
• Strong experience managing FDA, EMA, and other global health authority interactions, including regulatory meetings and negotiations.
• Experience developing regulatory strategies for pivotal clinical trials, registration, and commercialization.
• Strong cross functional collaboration across Clinical Development, Clinical Operations, CMC, Quality, and Commercial teams.
• Demonstrated experience building, leading, and mentoring Regulatory Affairs teams.
• Ability to balance strategic regulatory leadership with hands on submission preparation and execution in a small biotech environment.

Our team will review applications and reach out to candidates whose experience aligns with the role.