Director, Regulatory Affairs Liaison – Vaccines, Infectious Diseases

MSD

Principal Scientist in Global Regulatory Affairs managing regulatory strategy in Vaccines and Infectious Diseases. Responsible for regulatory oversight and global communication with FDA and foreign agencies.

Posted 6/29/2026full-timeNorth Wales • Maryland, Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $210,400 - $331,100 per yearWebsite

About the role

Key responsibilities & impact

responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area
provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact
develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
provides leadership as head of the Global Regulatory Team, which coordinates cross-functional regulatory support for development programs and marketed products
represents our company with external organizations through direct communication with the FDA
leads cross-functional efforts to prepare for advisory committees
coordinates interactions with foreign agencies to support their interactions and provide strategic direction across multiple regions simultaneously
reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators Brochures before release from our company to external agencies and investigators

Requirements

What you’ll need

M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
required experience: M.D. with minimum of 3 years relevant drug development or clinical experience required, or Ph.D. with minimum of 5 years relevant drug development experience required, or M.S. with minimum of 7 years relevant drug development or clinical experience
excellent communication skills (both oral and written)
good organizational skills with a proven ability to simultaneously balance diverse activities or multiple projects
flexibility required
strong scientific and analytical skills with attention to detail
ability to achieve optimal results with limited day-to-day direction from the manager
substantial experience in regulatory affairs preferred
therapeutic area experience in vaccines or infectious diseases preferred
experience with antibacterial, antifungal or antiviral agents preferred

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 OversightWorldwide Marketing Applications ReviewClinical Study Reports ApprovalProtocol DevelopmentInvestigators Brochures ReviewAnalytical SkillsAttention to DetailDrug DevelopmentClinical ExperienceProject Management

Soft Skills

Excellent Communication SkillsOrganizational SkillsFlexibilityAbility to Balance Multiple Projects

Certifications

M.D.Ph.D.M.S.