Executive Director, Enterprise Regulatory Policy Strategy

Job Description

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.

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:

• 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.

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 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.

• 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

• Excellent command of English (written and spoken)

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:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

The salary range for this role is

$231,900.00 - $365,000.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

08/14/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.