Global Regulatory Strategy Lead – Biotech Therapeutics

Trimaren Human Capital Partners; Watertown (TN); On-site; USD 220,000 - 320,000; Full time

Job summary

Confidential Biotech in Massachusetts seeks a Head of Regulatory Affairs to lead enterprise-level regulatory strategy across late preclinical and development programs. This role partners with R&D, Clinical, CMC, Quality, and Legal to accelerate product development and ensure compliant, science-driven decisions.

The candidate will guide FDA interactions, submissions, and regulatory planning, with a focus on biologics and precision medicine in a fast-moving stealth-mode environment.

Qualifications

• PhD or equivalent in life sciences; doctorate strongly preferred.
• 15+ years in regulatory affairs in biotech/pharma; director-level experience.
• Deep knowledge of FDA, ICH, and global regulatory submission strategy.
• Experience guiding biologics or precision medicine programs.
• Strong analytical, judgement, and decision-making skills.
• Excellent written English for regulatory documents.

Responsibilities

• Define and lead global regulatory strategy across late preclinical and development programs.
• Translate data into regulatory pathways and risk-adjusted development plans.
• Prepare and submit IND/CTA amendments and regulatory documents.
• Direct regulatory interactions with FDA and health authorities.
• Collaborate cross-functionally to shape development plans and labeling.
• Assess data for regulatory implications and fill evidence gaps.
• Monitor evolving regulations and incorporate into strategy.
• Build and mentor regulatory talent and operations.

Skills

Regulatory leadership

Strategic thinking

Regulatory strategy

Cross-functional collaboration

Technical writing

English proficiency

Education

PhD in Life Sciences

Job description

Confidential Biotech in Massachusetts seeks a Head of Regulatory Affairs to lead enterprise-level regulatory strategy across late preclinical and development programs. This role partners with R&D, Clinical, CMC, Quality, and Legal to accelerate product development and ensure compliant, science-driven decisions.

The candidate will guide FDA interactions, submissions, and regulatory planning, with a focus on biologics and precision medicine in a fast-moving stealth-mode environment.