Regulatory Project Manager, Strategy – CMC RA Small Molecules Mature Products

GSK

CMC regulatory project manager guiding small-molecule lifecycle submissions and FDA interactions at GSK. Supporting marketed medicines, compliance, and continuous supply across global markets.

Posted 9/8/2026full-timeDurham • North Carolina, Pennsylvania • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC regulatory affairs for small molecules, including lifecycle management and regulatory submissions. Proven ability to collaborate with cross-functional teams and maintain compliance with U.S. regulatory requirements.

Highest-signal resume keywords

CMC Regulatory AffairsRegulatory SubmissionsU.S. Regulatory RequirementsGood Manufacturing PracticesCross-Functional Collaboration

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentVariation Dossier AuthoringLifecycle ManagementRegulatory ComplianceRegulatory Agency InteractionQuality-Check CMC ContentElectronic Dossier FormatsPost-Approval ActivitiesChange Control ManagementRegulatory Gap Identification

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationAttention to DetailInfluencing StakeholdersNegotiation Skills

Industry Keywords

PharmacyChemistryPharmaceutical SciencesSmall MoleculesRegulatory Matrix TeamsFDA InteractionsMatrix EnvironmentContinuous ImprovementBest PracticesManufacturing Changes

About the role

Key responsibilities & impact

Provide CMC support to a defined portfolio of marketed small-molecule drug substances and products for global markets
Maintain global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in cross-functional Regulatory Matrix Teams
Partner with Technical, Quality, manufacturing, and other cross-functional teams to provide strategic regulatory advice for change controls
Develop regulatory strategies and plans through implementation
Lead authoring of variation dossiers and responses to Regulatory Agency questions
Develop CMC strategy for submission documents supporting marketed product lifecycle management
Ensure lifecycle maintenance submissions meet regional requirements and support supply, production, and quality flexibility
Prepare, review, and quality-check CMC content for regulatory filings, post-approval variations, and maintenance submissions
Act as primary U.S. regulatory contact for agency interactions, written questions, and meeting preparation
Advise cross-functional teams on U.S. and global CMC regulatory requirements and timelines to support supply continuity
Identify regulatory gaps, propose mitigations, and coordinate actions with stakeholders
Maintain regulatory compliance and share best practices and learnings
Provide CMC subject matter expertise and support continuous improvement of regulatory processes

Requirements

What you’ll need

Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline, or equivalent experience
Minimum of 2 years’ experience in CMC regulatory affairs focused on small molecules, including lifecycle management and post-approval activities or closely related discipline
Direct experience preparing or contributing to CMC sections of regulatory submissions for the U.S. market
Six or more months experience with U.S. regulatory requirements and guidance relevant to CMC, including Good Manufacturing Practices
Experience leading U.S. regulatory interactions and meeting preparation with the FDA
Demonstrated ability to work in cross-functional teams with development, manufacturing and quality colleagues
Strong written and verbal communication skills with attention to detail
Experience managing multiple product dossiers and competing priorities in a matrix environment
Experience supporting inspections or providing regulatory input for manufacturing changes
Knowledge of electronic dossier formats and submission processes
Proven ability to influence stakeholders and negotiate technical-regulatory resolutions

Benefits

Comp & perks

Comprehensive benefits program for US employees (details provided in GSK US Benefits Summary)