Senior Scientist, Regulatory Affairs – CMC, Synthetic Moieties, ADCs, Bioconjugates

MSD

. Serve as Regulatory CMC Lead for the synthetic moiety (Drug-Linker) of assigned ADC and other bioconjugate programs .

Posted 9/24/2026full-timeUnited StatesSenior💰 $117,000 - $184,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory CMC strategies for drug-linkers and bioconjugates, with a strong focus on compliance and regulatory submissions. Proven ability to lead cross-functional teams and manage complex documentation throughout the product lifecycle.

Highest-signal resume keywords

Regulatory CMCDrug-Linker DevelopmentRegulatory SubmissionsAnalytical ChemistryCompliance Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Affairs ManagementProcess ChemistryAnalytical DevelopmentCMC Product DevelopmentDrug DevelopmentECTDDocument CoordinationQuality AssurancePharmaceuticsBioconjugation

Soft Skills

LeadershipCollaborationRisk AssessmentCommunication

Tools & Technologies

INDsIMPDsBLAsMAAsHealth Authority Interactions

Industry Keywords

Antibody Drug ConjugatesChemically Synthesized ModalitiesOligonucleotidesExternal ManufacturingGlobal Life-Cycle Management

About the role

Key responsibilities & impact

Serve as Regulatory CMC Lead for the synthetic moiety (Drug-Linker) of assigned ADC and other bioconjugate programs
Provide regulatory leadership within Regulatory and cross-functional teams
Deliver all regulatory milestones through product development and post-approval lifecycle
Develop and execute phase-appropriate global Regulatory CMC strategies for drug-linkers, payloads, linkers, peptides, and other chemically synthesized moieties
Assess global regulatory CMC requirements and identify potential risks
Integrate synthetic-moiety regulatory strategy with targeting component, conjugation process, conjugated drug substance, and drug product strategies
Align dossier content, data requirements, and regulatory milestones
Manage preparation and execution of CMC documentation, including INDs, IMPDs, BLAs, MAAs, post-approval submissions/variations, agency meeting packages, and responses to health authority questions
Manage change controls and develop regulatory filing strategies
Conduct activities with an unwavering focus on compliance

Requirements

What you’ll need

B.S. in a science, engineering, or related field; Chemistry, Chemical Engineering, or Biochemistry fields included
At least 5 years of Regulatory CMC or directly relevant pharmaceutical development experience in small molecules or other chemically synthesized modalities
Experience in process chemistry, analytical development, manufacturing, testing, quality, technical operations, or CMC product development
Experience supporting CMC regulatory submissions, health authority interactions, or development of drug-linkers, payloads, ADCs, peptides, oligonucleotides, or other bio-conjugate or new-modality products preferred
Experience with external development or manufacturing partners and global life-cycle management preferred
Knowledge of Analytical Biochemistry, Analytical Chemistry, Antibody Drug Conjugates (ADC), Biochemistry, Bioconjugation, Chemistry, Document Coordination, Drug Development, Drug Formulations, eCTD, External Manufacturing, Ligand Binding, Pharmaceutics, Process Chemistry, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, and Regulatory Documents
Advanced degree preferred
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
Hybrid work arrangement