Executive Director, Regulatory Affairs Liaison

MSD

Executive Director leading global regulatory strategy for ophthalmology programs. Engaging health authorities and overseeing multiple regulatory initiatives across the company's portfolio.

Posted 4/29/2026full-timeRahway • Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $231,900 - $365,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.
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.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategydrug developmentNDA approvalsBLA approvalsregulatory submissionslabelinglocal registration study protocolsscientific knowledgeproject managementresource allocation

Soft Skills

leadershipcommunicationinterpersonal skillsnegotiation skillsteam buildingindependent results deliverycollaborationoversightstaff developmentstrategic input

Certifications

B.S. in biological scienceM.S. in biological scienceM.D.Ph.D.PharmD