Principal Scientist, Regulatory Liaison – Immunology

MSD

. Develop worldwide product regulatory strategies for assigned indications to optimize labeling and obtain the shortest time to approval .

Posted 10/2/2026full-timeRemote • United StatesLead💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing global regulatory strategies and managing regulatory submissions across major markets, including FDA and EMA. Possesses strong leadership and communication skills to effectively influence and negotiate with cross-functional teams and regulatory agencies.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentRegulatory Filings LeadershipRegulatory Affairs ManagementDrug Development ExperienceImmunology Therapeutic Area Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory ProcessesRegulatory CommunicationsINDs/CTAs PreparationClinical Study Protocol ReviewRegulatory ReviewProduct RegistrationsRegulatory Due DiligenceCross-Functional CoordinationProject Management

Soft Skills

Strategic ThinkingProblem-SolvingEffective CommunicationInfluencing SkillsNegotiation Skills

Industry Keywords

Pharmaceutical IndustryRegulatory AffairsDrug DevelopmentGlobal RegulatoryHealth AuthoritiesFDAEMAU.S. MarketEU MarketImmunology

About the role

Key responsibilities & impact

Develop worldwide product regulatory strategies for assigned indications to optimize labeling and obtain the shortest time to approval
Assess regulatory and competitive landscapes to establish global regulatory strategies that facilitate speed-to-market and targeted product labeling
Provide expert advice as Global Regulatory Lead to Product Development Teams
Serve as the regulatory point of contact for products within and external to GRACS throughout the drug life cycle
Lead the Global Regulatory Team coordinating cross-functional regulatory support for development programs and marketed products
Coordinate preparation, submission, and follow-up with regulatory agencies and subsidiaries for applications and submissions
Conduct regulatory review and final approval of submissions and associated documentation
Review and provide final approval of local registration study protocols when needed for marketing authorization in secondary markets
Interact independently with regulatory agencies including FDA and EMA through meetings, teleconferences, and written communications
Coordinate regional regulatory strategy and submissions with Regulatory Affairs Europe and local affiliate teams
Review worldwide marketing applications, clinical study reports, protocols, and investigator brochures
Prepare INDs/CTAs for global studies involving investigational drugs and biologics
Participate in regulatory due diligence for licensing candidate reviews
Independently manage complex projects as the accountable global point of contact

Requirements

What you’ll need

B.S. or M.S. with a minimum of 7 years of relevant drug development experience, with the majority in regulatory, OR M.D. or PhD/PharmD with a minimum of 5 years of relevant drug development experience, including three years in regulatory
Strong strategic thinking, problem-solving, and continuous learning mindset
Effective written and verbal communication skills
Ability to influence, lead, and negotiate across levels and functions
Experience leading or supporting direct interactions with major Health Authorities, such as FDA and EMA
Demonstrated expertise leading regulatory filings across global regions
Therapeutic area expertise in immunology preferred
Small and large molecule experience preferred
Regulatory affairs experience in major markets (U.S., EU, Japan, China) preferred
Experience in drug development, global regulatory, pharmaceutical industry, pharmaceutical research, product registrations, regulatory affairs management, regulatory communications, regulatory processes, regulatory strategies, regulatory submissions, and strategic leadership
Immunology preferred
US and Puerto Rico residency eligibility stated
No visa sponsorship available

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Remote work arrangement