Principal Scientist, Regulatory Liaison

MSD

Principal Scientist at global health care leader overseeing regulatory strategies for vaccines and infectious diseases. Collaborating across teams and engaging with regulatory agencies throughout drug development.

Posted 7/29/2026full-timeNorth Wales • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing global regulatory strategies for vaccines and infectious diseases, with a strong focus on optimizing product labeling and approval timelines. Possesses advanced scientific knowledge and leadership capabilities to guide cross-functional teams and manage regulatory interactions effectively.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentRegulatory OversightDrug Development ExperienceLeadership in Regulatory AffairsCommunication with FDA

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyDrug DevelopmentClinical Study ReviewInvestigational New Drug ApplicationWorldwide Marketing ApplicationsClinical Study Agreement ReviewRegulatory Due DiligenceLabel OptimizationProduct Approval ProcessRegulatory Affairs

Soft Skills

Excellent Communication SkillsOrganizational SkillsFlexibilityAttention to DetailAnalytical Skills

Certifications & Qualifications

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

Industry Keywords

VaccinesInfectious DiseaseRegulatory AgenciesFDACross-Functional TeamsAdvisory CommitteesBiological ScienceChemistryClinical ExperienceRegulatory Affairs Europe

About the role

Key responsibilities & impact

Responsible for development and implementation of global regulatory strategy for assigned projects in the Vaccines and Infectious Disease therapeutic area
Functions with a high degree of independence and provides regulatory oversight for assigned products
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
Provides leadership as head of the Global Regulatory Team
Represents company with external organizations through direct communication with the FDA
Leads cross-functional efforts to prepare for advisory committees
Coordinates interactions with foreign agencies through Regulatory Affairs Europe
Reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols
Conducts initial Investigational New Drug application/Clinical Study Agreement content review and approval
Participates in regulatory due diligence activities for licensing candidate review

Requirements

What you’ll need

M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
M.D. with minimum of 3 years relevant drug development or clinical experience required
Ph.D. with minimum of 5 years relevant drug development experience required
M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in regulatory affairs
Excellent communication skills (both oral and written)
Good organizational skills with a proven ability to simultaneously balance 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.

Benefits

Comp & perks

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