Executive Director, Regulatory Affairs Liaison

MSD; Boston (MA); Hybrid; USD 232,000 - 365,000; Full time

Job summary

Merck & Co., Inc. in the United States is seeking an Executive Director, Regulatory Affairs Liaison to define and execute global regulatory strategy for ophthalmology programs within General Medicine.

You will lead a team of Global Regulatory Leads and interface with major health authorities. The role demands extensive NDA/BLA experience, leadership, and cross-functional collaboration to align development, evidence-generation, and commercialization.

Qualifications

• Ability to deliver results independently while aligned with leadership.
• Strong regulatory knowledge and global agency familiarity.
• Proven track record securing NDA/BLA approvals.
• Excellent interpersonal, communication, and negotiation skills.
• Experience leading high-performing teams or projects.

Responsibilities

• Develop and implement global regulatory strategy for ophthalmology programs.
• Oversee direct reports and partner with international regulators.
• Review regulatory deliverables and labeling for accuracy and consistency.
• Lead performance reviews, resource allocation, and staff development.
• Represent the company at regulatory meetings and internal committees.
• Contribute to regulatory due diligence for licensing candidates.

Skills

Leadership

Regulatory Affairs

NDA/BLA approvals

Strategic thinking

Team management

Education

MD/PhD/PharmD

B.S./M.S. in biological science

Job description

Job Description

Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset, demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism.

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.

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:

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.

Position Description

The Executive Director, Regulatory Affairs Liaison reports to the Vice President (VP), General Medicine, and is accountable for defining and executing global regulatory strategy for assigned ophthalmology programs. This role provides strategic oversight across ophthalmology programs in the General Medicine Therapeutic Area, ensuring regulatory objectives are aligned with development, evidence-generation, and commercialization priorities. The Executive Director leads and develops a team of Global Regulatory Leads (GRLs), sets standards for regulatory excellence across multiple complex programs, and serves as an authoritative regulatory expert in ophthalmology drug development. As a senior regulatory leader, the individual represents the function on enterprise governance bodies and in external engagements with major health authorities and is regarded as an internal regulatory subject matter expert.

Key Responsibilities

• Oversee the development and implementation of global regulatory strategy for ophthalmology and retinal disease programs for multiple indications to minimize time to approval and optimize labeling.

• Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.

• Oversee strategy, review and approve key regulatory deliverables, including submissions, external communications (e.g., press releases), background packages, local registration study protocols, and labeling, to ensure accuracy and consistency.

• Lead, manage, and review the performance of direct reports, including oversight of regulatory strategy, resource allocation for respective projects, and staff development.

• Represent the company at external initiatives, regulatory authority meetings, and internal committees as required.

• Provide strategic input into regulatory due diligence activities for licensing candidate review.

Minimum Education Requirements

• B.S./M.S. in biological science or related discipline with a minimum of 12 years of relevant drug development experience, with a majority in regulatory affairs.

• M.D./Ph.D. or PharmD. with a minimum of 9 years relevant drug development experience, with at least 7 years in regulatory.

Required Experience and Skills

• Demonstrated ability to deliver results independently while remaining aligned with leadership.

• Demonstrated scientific knowledge, effective communication, and thorough familiarity with worldwide regulatory agencies.

• Demonstrated success in securing original NDA/BLA approvals.

• Outstanding interpersonal, communication, and negotiation skills.

• Demonstrated leadership attributes, including experience building and leading high-performing teams or projects.

Preferred Experience and Skills

• Regulatory experience in retinal disease and ophthalmology programs.

• People management experience.

• Substantial experience with both small and large molecule development programs.

• Extensive experience in U.S. and international regulatory affairs, with prior experience as a Global Regulatory Lead.

Additional Information

• Extent of Travel: 10%

• Geographical Scope: U.S. and global regulatory responsibility

Required Skills

Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}

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.

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

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/9/2026

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

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