Head of Regulatory Legal

Job Description

About the role:

The Head of Regulatory Legal is responsible for developing and leading the global legal strategy supporting Global Quality (GSQ), Research & Development (R&D), Regulatory Affairs, and Plasma Derived Therapies (PDT) across the enterprise. This role provides high‑level legal counsel on regulatory matters (FDA, EMA, and other global agencies), manufacturing, supply chain, and the product development lifecycle from research through clinical trials.

As a trusted advisor to senior leadership, the Head of Regulatory Legal leads a team of legal professionals, ensures compliance with all relevant laws and regulations, mitigates legal and regulatory risks, and collaborates across business units. This position demands deep pharmaceutical law expertise, strong leadership, and proven ability to drive cross‑functional innovation and continual improvement.

• Provide end‑to‑end oversight and deliver high‑quality legal support to global teams operating in GSQ, R&D, Regulatory Affairs, and PDT.
• Deliver strategic legal guidance to senior leadership on all regulatory, manufacturing, and quality‑related matters, ensuring robust compliance and risk mitigation across the enterprise.
• Actively participate as a member of an executive leadership team, collaborating on strategic initiatives and decision‑making.
• Oversee and develop legal professionals who represent legal on other executive leadership teams.
• Develop, lead, and inspire a legal team that effectively addresses complex legal and regulatory issues, including leading cross‑functional project teams such as PDT and Regulatory.
• Identify and mitigate legal and regulatory risks across the organization, advising on best practices and strategic approaches.
• Oversee the company’s compliance with all applicable laws and regulations, designing and implementing effective regulatory strategies and managing legal and regulatory teams globally.
• Demonstrate legal innovation and cross‑functional leadership, driving initiatives that extend beyond traditional legal boundaries to deliver enterprise‑wide solutions.
• Apply an enterprise mindset and critical thinking in resolving complex issues with significant business impact, championing continual improvement in processes, technology, and agility.
• Foster strong collaboration within the legal function and with business units and functions across the organization.

Preferred Qualifications:

• Juris Doctor (JD) degree and active law license within relevant jurisdiction.
• Advanced professional training in pharmaceutical law from a highly regarded law firm.
• 15+ years of post‑qualification legal experience advising on complex regulatory issues, including regulatory affairs, clinical trials, manufacturing, quality, and supply chain matters within the pharmaceutical or biotechnology industries.
• Significant in‑house experience in the pharmaceutical or biotech industry, with a track record of increasing responsibility.
• Demonstrated experience managing attorneys and legal professionals at all levels.

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For

Location:

Boston, MA

U.S. Base Salary Range:

$ - $

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic…