About This Role
Leading the global legal strategy for Global Quality (GSQ), Research & Development (R&D), Regulatory Affairs, and Plasma Derived Therapies (PDT) across the company is the core of this role. As a trusted advisor, the Head of Regulatory Legal provides high-level legal counsel on regulatory matters, manufacturing, supply chain, and the product development lifecycle from research through clinical trials, leading a team of legal professionals to ensure compliance and mitigate risks. This position requires deep pharmaceutical law expertise, strong leadership, and a proven ability to drive cross-functional innovation and continual improvement.
Responsibilities
- 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
Requirements
- 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
