Executive Director, Regulatory Affairs Liaison

Merck & Co.; Rahway (NJ); Hybrid; USD 219,000 - 365,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical benefits

401(k)

Job summary

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

You will lead a team of Global Regulatory Leads and interact with health authorities worldwide to ensure timely, compliant submissions. This senior role requires a track record of NDA/BLA approvals, leadership of cross-functional teams, and strategic insight into licensing and due diligence.

Qualifications

• Experience delivering regulatory strategies for drug development.
• Proven track record in NDA/BLA approvals.
• Strong communication and leadership abilities.

Responsibilities

• Oversee global regulatory strategy for ophthalmology programs.
• Lead and develop a team of Global Regulatory Leads.
• Review and approve regulatory deliverables and submissions.
• Represent the company with health authorities and committees.
• Provide input into regulatory due diligence for licensing.

Skills

Regulatory strategy

Leadership

Global regulatory

NDA/BLA approvals

Education

Bachelor's degree in biological science

MD/PhD or PharmD with regulatory

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.

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}

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 .

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

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 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.

Requisition ID: R391555