Executive Director, Regulatory Affairs Liaison

Merck•Boston, MA

3d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.