Associate Principal Scientist, Regulatory Affairs

MSD

. Implement Chemistry, Manufacturing, and Controls regulatory strategies for biologics product franchises under direction from the Director/Executive Director .

Posted 9/28/2026full-timeUnited StatesSeniorLead💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics, with a strong focus on authoring submissions such as INDs and BLAs. Proven ability to mentor teams, manage projects, and communicate effectively in multicultural environments.

Highest-signal resume keywords

Biologics Chemistry, Manufacturing, And Controls ExpertiseIND And BLA Submission ExperienceRegulatory Strategy DevelopmentLeadership And Mentoring SkillsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission AuthoringGlobal Regulatory Strategy DevelopmentCMC Regulatory AssessmentsClinical Trial Application PreparationBiologics Development ExpertiseAnalytical ReviewProcess Development KnowledgeQuality Assurance UnderstandingComplex Dosage Forms ExperienceAntibody-Drug Conjugates Knowledge

Soft Skills

Superior Oral And Written CommunicationInterpersonal SkillsNegotiation SkillsFlexibility In Changing PrioritiesProblem-Solving Skills

Industry Keywords

Investigational New Drug ApplicationBiologics License ApplicationPost-Approval FilingRegulatory ComplianceMulticultural CommunicationProject TrackingSubmission AuthorizationTeam CollaborationScientific ExcellenceGlobal Submission Guidelines

About the role

Key responsibilities & impact

Implement Chemistry, Manufacturing, and Controls regulatory strategies for biologics product franchises under direction from the Director/Executive Director
Prepare and submit CMC sections for commercial or new biologics products
Assist in developing and implementing internal regulatory strategies
Mentor and coach Senior Scientists and Scientists on assigned projects
Participate in submission authorization and prioritization processes
Complete global regulatory assessments according to guidelines, policies, and timelines
Develop and execute global regulatory strategies for INDs, BLAs, and post-approval change documentation
Plan, track, and communicate submissions and approvals to support continued product supply
Lead authoring of Clinical Trial Applications, INDs, BLAs, and global post-approval submissions
Collaborate with partner groups to ensure submission compliance, scientific excellence, accuracy, and completeness
Resolve project issues through team collaboration and escalation to CMC leadership
Participate in early and late development programs and cross-functional efforts to improve CMC content or processes

Requirements

What you’ll need

B.S. in a science, engineering, or related field required; advanced degree preferred
At least 10 years of subject matter expertise in biologics Chemistry, Manufacturing, and Controls development or manufacturing
Prior biologics Investigational New Drug Application (IND), License Application (BLA), and/or post-approval filing experience
Experience in biologics regulatory Chemistry, Manufacturing and Control in both pre-approval and registration
Experience authoring agency interactions, responses to questions, and IND, Investigational Medicinal Product Dossier, and BLA sections
Understanding of related fields such as manufacturing, process development, analytical, and quality assurance
Ability to critically review detailed scientific information and assess technical arguments and data-supported conclusions
Superior oral and written communication skills in multicultural settings
Ability to respond flexibly to changing priorities and unexpected events
Leadership, project management, communication, interpersonal, and negotiating skills
Ability to generate innovative solutions to complex regulatory problems and communicate effectively with key stakeholders
Experience with antibody-drug conjugates, combination products, and/or complex dosage forms through commercialization preferred
US and Puerto Rico residency/work eligibility

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, and vision healthcare benefits for employee and family
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Accommodation during the application or hiring process