Executive Director, Enterprise Regulatory Policy Strategy

Merck • Rockville, MD

9d • $231,900 - $365,000 • Hybrid

About The Position

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. The ED will lead a highly collaborative, regionally distributed function focused on shaping, aligning, and advancing enterprise regulatory policy strategy across regions, including synthesis of policy intelligence, analysis of regulatory environments, and alignment of external advocacy approaches. The ED will work closely with the Global Regulatory Policy lead, including U.S. and regional policy experts, along with public policy and technical subject matter experts within our company to assess the impact of regulatory policy on the company’s products and goals. The role serves as a critical integrator across Most of World (MOW), global, and U.S. regulatory policy stakeholders, with primary responsibility for overseeing and aligning MOW policy approaches while deliberately layering in U.S. & therapeutic area considerations. The role helps shape enterprise regulatory policy strategy and global/ MOW messaging to ensure consistent internal alignment and effective external delivery at the level of major trade associations, as well as through country specific trade associations, regulatory affairs led engagements, and professional associations attended by subject matter experts.

Requirements

• Bachelor’s Degree is required, preferably in science, health care, public health or health policy or a related field
• Advanced degree (Master’s, Doctorate, or JD) strongly preferred.
• Doctorate degree and at least 5 years’ experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR Master’s degree and at least 8 years’ experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR Bachelor’s degree and at least 10 years’ experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority), with demonstrated senior level experience engaging health authorities.
• 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 and 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 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.
• Excellent command of English (written and spoken)

Nice To Haves

• 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.

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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Executive