Executive Director, Regulatory Affairs Liaison

Merck; Rahway (NJ); On-site; USD 232,000 - 365,000; Full time

Job summary

Merck's Regulatory Affairs team in General Medicine seeks a high-level leader to define global regulatory strategy for ophthalmology programs. You will oversee a team of Global Regulatory Leads, ensuring regulatory excellence across complex projects and acting as a subject-matter expert in ophthalmology drug development.

As a senior regulatory executive, you will interface with health authorities worldwide and participate in enterprise governance.

Qualifications

• Demonstrated ability to deliver results independently while aligned with leadership.
• Thorough familiarity with worldwide regulatory agencies.
• Experience leading regulatory strategy for ophthalmology programs.
• Strong interpersonal, communication, and negotiation skills.

Responsibilities

• Oversee global regulatory strategy for ophthalmology and retinal disease programs to minimize time to approval and optimize labeling.
• Provide oversight for direct reports and collaborate with international regulatory colleagues and health authorities.
• Review and approve regulatory deliverables including submissions, external communications, and labeling.
• Lead performance of direct reports, allocate resources, and develop staff.
• Represent the company at regulatory meetings and internal governance bodies.
• Contribute strategic input into regulatory due diligence for licensing candidates.

Skills

Regulatory strategy

Global health authorities

NDA/BLA approvals

Leadership

Communication

Regulatory affairs management

Education

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

M.D./Ph.D. or PharmD.

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}

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.

Requirements

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:

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Salary

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