Global VP, Regulatory Affairs — Phase 3 & BLA Strategy

Trebla Talent; Massachusetts; On-site; USD 250,000 - 350,000; Full time

Job summary

Trebla Talent is seeking a Vice President / Senior Vice President of Regulatory Affairs in the Greater Boston area to lead global regulatory strategy for late-stage programs, guiding Phase 3 activities, registration, and pre-commercial milestones.

The role requires 15+ years in Regulatory Affairs, strong leadership, and a track record with BLA/NDA submissions across the U.S. and Europe. Onsite presence is expected Tuesday–Thursday in the Boston/Waltham region.

Qualifications

• 15+ years of Regulatory Affairs experience in biotech/pharma, with late-stage development exposure.
• Experience leading or coordinating BLA/NDA submissions and pre-launch activities.
• Strong global regulatory expertise across U.S. and Europe, including nontraditional pathways.
• Proven senior leadership capable of building teams and influencing executives in a growing biotech.

Responsibilities

• Lead global regulatory strategy for late-stage programs (Phase 3, registration).
• Guide development plans, trial endpoints, labeling, and health authority strategy with cross-functional teams.
• Manage interactions with FDA, EMA, Health Canada, and external partners.
• Build and evolve the Regulatory Affairs function, including team structure and processes.

Skills

Regulatory strategy

Late-stage development

Global regulatory

Leadership

Job description

Trebla Talent is seeking a Vice President / Senior Vice President of Regulatory Affairs in the Greater Boston area to lead global regulatory strategy for late-stage programs, guiding Phase 3 activities, registration, and pre-commercial milestones.

The role requires 15+ years in Regulatory Affairs, strong leadership, and a track record with BLA/NDA submissions across the U.S. and Europe. Onsite presence is expected Tuesday–Thursday in the Boston/Waltham region.