Regulatory Manager, Strategy – CMC RA Vaccines Development Projects
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Posted: 10/20/2026
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Role fitCore Competencies
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Demonstrates expertise in Chemistry, Manufacturing and Controls (CMC) regulatory affairs, with a strong focus on developing and implementing regulatory strategies for investigational and commercial products. Proven ability to navigate global regulatory requirements and ensure compliance throughout the product lifecycle.
Highest-signal resume keywords
CMC Regulatory Affairs ExperienceRegulatory Submission PreparationDrug Development KnowledgeInterpersonal Communication SkillsRegulatory Strategy Development
About the role
Key responsibilities & impact- Responsible for CMC regulatory activities in investigational, late-phase development and/or early commercial lifecycle management of GSK products
- Lead global CMC regulatory activities for assigned projects and respond to changing events and priorities
- Develop CMC strategies for submission documents from early-phase clinical submissions (IND/IMPD) through marketing applications (NDA/BLA/MAA) and early lifecycle management activities
- Interpret and advise teams on regulations, guidelines, procedures and policies relating to medicinal product development, registration and manufacture
- Ensure CMC regulatory aspects for clinical trials and product release are in place to avoid clinical holds and maintain market supply
- Ensure clinical and marketing application information meets regional requirements while maximizing Supply/Production/Quality flexibility
- Work in cross-functional matrix project teams with regulatory, development, quality and manufacturing colleagues to define CMC filing strategy
- Maintain regulatory compliance, raise performance through continuous improvement, and share best practices and learnings
- Engage in internal CMC Subject Matter Expert activities to increase compliance, harmonisation and efficiency
- Deliver CMC regulatory strategy supporting major inspections, with managerial support
Requirements
What you’ll need- BSc Life sciences or related scientific discipline (or PhD)
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions
- Sound knowledge of drug development, manufacturing processes and supply chain; may have a specialized area of expertise
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering compliant dossiers, particularly for new medicines in development
- Good time management skills and ability to plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to meet tight deadlines
- Continued professional growth in global regulatory affairs, including communication of evolving/emerging trends and policies
- Broad knowledge across regulatory functions and understanding of wider implications of emerging issues across projects
- Experience influencing and negotiating with company personnel and regulatory agencies in a variety of settings
- Strong interpersonal, presentation and communication skills with established internal networks
- Ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy
- Demonstrated ability to handle global CMC issues through continuous change and improvement
- Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change, or key development interactions at EOP2/pre-Phase 3 or other regulatory interactions in early development)
- May be identified as a CMC Regulatory expert in a specific subject area
- Proactively seeks out and recommends process improvements
Benefits
Comp & perks- Annual bonus may be offered
- Eligibility to participate in a share-based long-term incentive program, depending on the role level
- More detailed total benefits package information supplied during recruitment
- Assistance and suitable arrangements available during the selection process for candidates with disabilities
ATS Keywords
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Hard Skills
CMC Regulatory AffairsRegulatory Submission PreparationDrug DevelopmentManufacturing ProcessesRegulatory ComplianceFiling Activities (MAA/NDA/BLA)Continuous ImprovementProject CoordinationRegulatory Requirements KnowledgeSubject Matter Expertise
Soft Skills
Time ManagementPresentation SkillsNegotiation SkillsInterpersonal SkillsAdaptability
Certifications & Qualifications
BSc Life SciencesPhD (Preferred)
Industry Keywords
Investigational ProductsClinical TrialsMarket SupplyGlobal Regulatory AffairsEmerging TrendsCross-Functional TeamsRegulatory AgenciesProduct Lifecycle ManagementCompliance DossiersQuality Flexibility