Executive Director, Enterprise Regulatory Policy Strategy

Job Overview The Science and Regulatory Policy team is responsible for developing our company’s science and regulatory policy positions and advocating those towards industry thought leaders and regulators. The Executive Director, Enterprise Regulatory Policy Strategy provides strategic direction for our company’s enterprise‑level regulatory policy approach across regions and markets. The Executive Director (ED) will be a strong subject‑matter expert in regulatory processes, policies, laws, and regulations, with a deep understanding of how regulatory policy is shaped and influenced, and the credibility, relationships, and strategic judgment required to drive alignment and advance regulatory policy priorities in direct support of our Research and Development (R&D) goals, including enabling timely filings and accelerating pipeline progression through consistent, high‑impact external policy engagement. Primary Responsibilities Provides strategic direction, oversight, and mentorship to regional regulatory policy leads representing our company externally across markets. Proactively monitors and synthesizes regulatory policy developments across regions and markets to provide a strategic view of emerging issues and identify opportunities to influence the environment favorably for our company business and the product portfolio. Engages with key company stakeholders to align enterprise regulatory policy positions and inform global regulatory policy strategy. Develops and executes strategies for advancing regulatory policy goals through regional and market‑based trade associations, coalitions, and policy forums. Guides and supports regional policy leads in representing our company externally, reinforcing consistent positioning, advocacy priorities, and escalation pathways across markets. Represents our company in selected regional or cross‑market policy forums, as appropriate. Facilitates alignment and information flow between regional policy teams and global internal stakeholders on issues with cross‑regional or enterprise impact. Collaborates closely with Global Public Policy, Regulatory Affairs, R&D, and other key stakeholders to ensure enterprise regulatory policy strategy is aligned across functions and regions. Works in close partnership with global and U.S. regulatory policy leadership to support alignment without duplicating defined accountabilities. Leads participation in regional and market‑based trade associations and technical working groups. Ensures our company representatives are aligned to enterprise policy positions and advocacy priorities, and that insights from external engagement are communicated effectively to internal stakeholders. Education & Qualifications Doctorate degree and at least 5 years’ experience with the FDA or other health authority, directly or indirectly, OR Master’s degree and at least 8 years’ experience with the FDA or other health authority, directly or indirectly, OR Bachelor’s degree and at least 10 years’ experience with the FDA or other health authority, directly or indirectly, with demonstrated senior‑level experience engaging health authorities. Bachelor’s Degree required in science, health care, public health or health policy or a related field. Advanced degree (Master’s, Doctorate, or JD) strongly preferred. Required Experience and Skills 4 years of managerial experience directly managing people and/or leadership experience in managing complex, multi‑regional teams, programs, or enterprise initiatives. Proven capability in acting as a credible, influential, and respected spokesperson and trusted advisor, with exceptional written and verbal communication skills, and the ability to synthesize and convey complex policy inputs into clear, concise, decision‑relevant guidance for senior and very senior leaders. Strong understanding of regulatory policy development processes and experience operating across complex, fluid, multi‑regional regulatory environments. Strong relationship management and interpersonal skills, with the ability to write and speak clearly, persuasively, and succinctly, and to operate in a client‑minded manner as an internal regulatory policy and strategy advisor—particularly supporting our company R&D Division. Proven success at stakeholder engagement across organizational levels and boundaries, including the ability to distill and manage divergent regional perspectives, technical detail, and relevant political context into a focused, enterprise‑relevant set of priorities and implications—both in writing and in senior‑level briefings. Ability to fully demonstrate our company’s leadership principles, driving strategic outcomes and managing high‑performing teams. Ability to thrive in a cross‑functional, multi‑regional environment with a strong enterprise mindset and a bias toward clarity and cohesion. Experience in private‑sector law, management consulting, policy consulting, or a similar advisory environment strongly preferred, reflecting the need to integrate broad inputs, exercise sound judgment, and deliver cohesive, enterprise‑focused recommendations. Ability to travel internationally on a quarterly basis. Required Skills Confidentiality Cross‑Cultural Awareness Detail‑Oriented Innovation Mentoring Staff People Leadership Policy Development Professional Networking Public Policies Regulatory Affairs Compliance Regulatory Affairs Management Regulatory Communications Regulatory Compliance Regulatory Policies Regulatory Strategy Development Regulatory Submissions Stakeholder Engagement Stakeholder Management Strategic Thinking Preferred Skills Private‑sector law, management consulting, policy consulting, or a similar advisory environment strongly preferred. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts. Salary and Benefits Salary range: $231,900.00 – $365,000.00. Benefits include medical, dental, vision, healthcare, other insurance benefits for employee and family, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. #J-18808-Ljbffr MSD Malaysia