Senior Director, Regulatory Affairs Liaison – General Medicine

MSD

Senior Principal Scientist overseeing regulatory strategy and execution for cardiovascular programs in General Medicine. Collaborating with global health authorities to optimize drug approval processes.

Posted 5/8/2026full-timeRahway • Maryland, Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $190,800 - $300,300 per yearWebsite

About the role

Key responsibilities & impact

Oversee the global regulatory strategy development and execution for their assigned programs in the cardiovascular/renal/respiratory therapeutic area to optimize labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
Provide expert advice as the GRL to Early Development Teams (EDT)/Product Development Teams (PDT)and regulatory single point-of-contact for products within and external to Global Regulatory Affairs and Clinical Safety (GRACS) on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
Provide leadership by leading the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs which coordinates global, cross-functional regulatory support for development programs and marketed products.
Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
Represent our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company teams for meetings with FDA at any phase of drug development
Coordinate interactions with global regulatory agencies through Regulatory Affairs Europe, Regulatory Affairs International, and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.

Requirements

What you’ll need

Degree in biological science or related discipline
B.S., with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs
M.S. with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs
M.D. with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs
PhD/PharmD with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs
Ability to achieve optimal results with limited day-to-day direction from the Therapeutic Area Lead
Outstanding interpersonal, verbal and written communication, and negotiation skills.
Demonstrated leadership attributes, including experience building and leading high-performing teams.

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 strategy developmentdrug developmentregulatory affairsmarketing authorizationlocal registration study protocolscross-functional regulatory supportFDA communicationglobal regulatory agencies coordinationtherapeutic area expertiseclinical safety

Soft Skills

leadershipinterpersonal skillsverbal communicationwritten communicationnegotiation skillsteam buildinghigh-performing team leadershipstrategic directionproblem-solvingcollaboration

Certifications

B.S.M.S.M.D.PhDPharmD