Head of Regulatory Affairs

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 | Stealth Mode | On-Site in MA

We are partnering with a well-capitalized, stealth-stage biotechnology company developing a differentiated therapeutic platform with the potential to address significant unmet medical needs.

The Head of Regulatory Affairs will provide enterprise-level regulatory strategy and execution leadership across a science-driven organization with deep expertise in tissue-targeted therapeutics. This is a high-impact regulatory leadership opportunity for a strategic partner, problem solver, and collaborator who can help shape the path from discovery through clinical development and toward registration.

In partnership with Research, Clinical Development, CMC, Quality, and senior leadership, you will help ensure regulatory decisions are grounded in rigorous science, aligned with global expectations, and positioned to support accelerated development for transformative therapies.

This role requires both strategic vision and operational precision in a fast-moving, mission-driven environment.

Responsibilities

• Define and lead global regulatory strategy across late preclinical and development programs, ensuring alignment with corporate objectives, clinical milestones, and long-range product planning.


• Serve as a trusted enterprise partner to senior leadership, translating scientific and clinical data into actionable regulatory pathways and risk-adjusted development plans.


• Lead preparation, review, and submission of high-quality regulatory documents, including IND/CTA amendments, briefing packages, meeting requests, annual reports, and related agency correspondence.


• Design and direct regulatory interactions with FDA and other health authorities, including strategy for scientific advice, end-of-phase meetings, and key development decision points.


• Collaborate cross-functionally to shape clinical development plans, nonclinical strategy, CMC readiness, and labeling considerations that support efficient advancement of the pipeline.


• Assess emerging data packages for regulatory implications, identify gaps, and guide teams in building evidence packages that support product development and lifecycle strategy.


• Monitor evolving regulations, guidance, and precedent relevant to cell-targeted biologics, rare disease development, and advanced therapeutic modalities, and incorporate insights into program strategy.


• Build and mentor regulatory talent and operations that strengthen decision-making, accountability, and execution across the organization.

Requirements

• Doctorate in a relevant scientific discipline strongly preferred; advanced degree or equivalent experience in biology, chemistry, medicine, or a related life sciences field.


• 15+ years of progressive regulatory affairs experience in biotechnology or pharmaceuticals, with demonstrated leadership at the director or vice president level.


• Deep knowledge of global regulatory frameworks, including FDA and ICH requirements, regulatory submission strategy, and clinical development governance.


• Strong command of biology, medicine, and chemistry as applied to biologic or precision medicine development, with the ability to interpret complex scientific datasets.


• Exceptional critical thinking, judgment and decision making, and complex problem-solving skills, with the ability to identify issues, assess tradeoffs, and recommend clear actions.


• Strong written comprehension and English language skills, with demonstrated excellence in authoring, reviewing, and editing regulatory documents and agency communications.


• Ability to collaborate effectively across R&D, Clinical, CMC, Quality, and Legal while influencing without authority and driving alignment among diverse stakeholders.


• Experience guiding programs in rare disease, hematology, biologics, or similarly regulated therapeutic areas is highly preferred.


• A track record of building regulatory strategy that supports development efficiency, operational readiness, and high-quality decision-making in evolving environments.