VP, Regulatory Affairs — Global Strategy for Biotech

Trimaren Human Capital Partners, LLC; Massachusetts; On-site; USD 260,000 - 400,000; Full time

Job summary

Confidential Biotech, a stealth-mode biotechnology company in Massachusetts, seeks a Head of Regulatory Affairs to lead global regulatory strategy from late preclinical through development, working with senior leadership and cross-functional teams. You will shape lifecycle plans, ensure regulatory readiness, and guide interactions with FDA and other agencies.

You will translate complex data into regulatory pathways, oversee high-quality submissions, and mentor regulatory professionals to

Qualifications

• Doctorate in a life sciences field strongly preferred.
• 15+ years of progressive regulatory affairs experience in biotechnology/pharmaceuticals at director or VP level.
• Deep knowledge of global regulatory frameworks (FDA/ICH) and submission governance.
• Strong ability to translate scientific data into regulatory strategy and plans.
• Proven leadership in cross-functional teams and enterprise partnerships.

Responsibilities

• Define and lead global regulatory strategy across late preclinical and development programs.
• Serve as enterprise partner to senior leadership, translating data into regulatory pathways and development plans.
• Lead preparation, review, and submission of regulatory documents (IND/CTA, briefing packages, meetings, annual reports).
• Direct regulatory interactions with FDA and other authorities, including scientific advice and end-of-phase meetings.
• Collaborate with R&D, Clinical Development, CMC, Quality, and Legal to shape development plans and labeling considerations.
• Assess data packages for regulatory implications, identify gaps, and guide evidence package building.
• Monitor evolving regulations and guidance for cell-targeted biologics and advanced modalities.
• Build and mentor regulatory talent and operations across the organization.

Skills

Regulatory strategy

FDA/ICH knowledge

Leadership

Cross-functional collaboration

Biotech/pharma

Education

Doctorate in a relevant science

Job description

Confidential Biotech, a stealth-mode biotechnology company in Massachusetts, seeks a Head of Regulatory Affairs to lead global regulatory strategy from late preclinical through development, working with senior leadership and cross-functional teams. You will shape lifecycle plans, ensure regulatory readiness, and guide interactions with FDA and other agencies.

You will translate complex data into regulatory pathways, oversee high-quality submissions, and mentor regulatory professionals to