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Global Regulatory Affairs Manager
GSKGlobal Regulatory Affairs Manager shaping oncology regulatory strategies and approvals at GSK, a global biopharma company. Coordinating submissions, compliance, and cross-functional development across regions.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and executing regulatory strategies for oncology assets, ensuring compliance with global, regional, and local requirements throughout the product lifecycle. Proficient in collaborating with cross-functional teams and managing submissions and approvals with regulatory authorities.
Highest-signal resume keywords
Regulatory AffairsOncology Drug DevelopmentClinical Trial RequirementsGlobal Regulatory StrategyMatrix Team Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Strategy DevelopmentDrug Development ProcessRegulatory ComplianceLabeling and ApprovalsRegulatory Intelligence Assessment
Soft Skills
Strong Written CommunicationStrong Verbal Communication
Tools & Technologies
Digital Fluency Tools
Certifications & Qualifications
Advanced Scientific Degree (PhD, MD, PharmD)
Industry Keywords
OncologyRegulatory RequirementsProduct LifecyclePerformance ExcellenceProcess Improvement
About the role
Key responsibilities & impact- Develop and execute global and regional regulatory strategies for oncology assets
- Ensure optimal labeling and approvals while maintaining compliance with internal and external requirements
- Collaborate with the Global Regulatory Lead, Global Regulatory Therapeutic Area Head, global/regional counterparts, local operating companies, and cross-functional teams
- Align regulatory plans with the Medicines Development Strategy and Integrated Asset Plan
- Support interactions, reviews, and submissions with regional and local regulatory authorities
- Assess regulatory intelligence, precedents, and competitive landscape to inform strategy and decision-making
- Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle
- Drive process improvement, innovation, and performance excellence through strategic changes
Requirements
What you’ll need- Bachelor’s degree in biological, pharmaceutical or healthcare science
- Proven experience in the drug development process, preferably in regulatory affairs and oncology
- Knowledge of clinical trial and licensing requirements in at least one major regional/global market
- Strong written and verbal communication skills
- Experience working effectively in matrix teams
- Ability to develop and deliver global and regional regulatory strategies
- Advanced scientific degree (PhD, MD, PharmD) preferred
- Ability to manage global and regional development, submission, and approval activities preferred
- Proficiency in digital fluency tools preferred
- Submit a CV and brief cover letter
Benefits
Comp & perks- Hybrid working pattern combining time in the office and remote work
- Agile working culture and flexibility opportunities
- Career development opportunities
- Supportive, inclusive environment where employees can thrive
- Opportunities to keep growing and look after wellbeing
- Equal opportunity employment