Senior Principal Scientist, Regulatory Liaison

MSD

. Develop and implement worldwide regulatory strategies for assigned General Medicine projects, with a focus on Immunology development programs .

Posted 10/5/2026full-timeRemote • United StatesSenior💰 $190,800 - $300,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing global regulatory strategies for drug development, particularly in Immunology, while effectively leading cross-functional teams and managing communications with regulatory agencies such as the FDA and EMA.

Highest-signal resume keywords

Global Regulatory AffairsRegulatory Strategy DevelopmentDrug DevelopmentRegulatory SubmissionsLeadership Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Affairs ManagementRegulatory ProcessesRegulatory DocumentsProduct RegistrationsRegulatory CommunicationsRegulatory StrategiesPharmaceutical ResearchImmunology ExpertiseSmall and Large Molecule ExperienceINDs/CTAs Preparation

Soft Skills

Strategic ThinkingProblem-SolvingEffective CommunicationInfluencing SkillsNegotiation Skills

Industry Keywords

Pharmaceutical IndustryHealth AuthoritiesFDAEMAGlobal MarketsU.S.EUJapanChinaTherapeutic Area Expertise

About the role

Key responsibilities & impact

Develop and implement worldwide regulatory strategies for assigned General Medicine projects, with a focus on Immunology development programs
Provide regulatory oversight to optimize product labeling and obtain the shortest time to approval from global regulatory agencies
Independently manage projects as the accountable global point of contact for project teams
Interact with worldwide regulatory agencies and subsidiaries regarding global regulatory strategy and registration requirements
Use regulatory and competitive landscapes to establish strategies that facilitate speed-to-market and targeted product labeling
Serve as Global Regulatory Lead and regulatory single point of contact throughout product life cycles
Lead Global Regulatory Teams coordinating cross-functional regulatory support
Coordinate preparation, submission, and follow-up communications with regulatory agencies
Review global applications and associated documentation
Review and provide final approval of local registration study protocols for secondary markets
Lead regulatory meetings, teleconferences, and written communications with agencies including FDA and EMA
Lead cross-functional preparation for FDA advisory committees
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

Requirements

What you’ll need

B.S. or M.S. with a minimum of 10 years of relevant drug development experience, with the majority in regulatory, OR M.D. or PhD/PharmD with a minimum of 7 years of relevant drug development experience, including five years in regulatory
Experience leading or supporting direct interactions with major Health Authorities, such as FDA and EMA
Expertise leading regulatory strategies across global regions
Global regulatory affairs experience in major markets: U.S., EU, Japan, and China
Strategic thinking, problem-solving, and continuous learning mindset
Effective written and verbal communication, with ability to influence, lead, and negotiate across levels and functions
Leadership experience building and leading high-performing teams or projects
Corporate and ethical integrity
Preferred: therapeutic area expertise in immunology
Preferred: small and large molecule experience
Preferred: prior people management experience
Required skills: Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Documents, Regulatory Processes, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Strategic Leadership
US and Puerto Rico residents only
No visa sponsorship

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 days
Sick days
Remote work arrangement