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GSK

Regulatory Affairs Manager, Oncology

GSK

. Develop and execute global and regional regulatory strategies for oncology assets .

Posted 10/23/2026full-timeLondon • United KingdomMid-LevelSenior💰 €98,250 - €163,750 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Expertise in developing and executing regulatory strategies for oncology assets, ensuring compliance with global and regional requirements while fostering collaboration across cross-functional teams. Proven ability to manage drug development processes and regulatory submissions effectively.

Highest-signal resume keywords
Regulatory Strategy DevelopmentOncology Drug DevelopmentRegulatory ComplianceClinical Trial RequirementsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory AffairsDrug Development ProcessLabeling and ApprovalsRegulatory IntelligenceSubmission ActivitiesPerformance ExcellenceProcess ImprovementInnovative Solutions
Soft Skills
Strong Communication SkillsCollaborative Environment FosteringProactive Problem Solving
Tools & Technologies
Digital Fluency Tools
Industry Keywords
OncologyBiological SciencePharmaceutical ScienceHealthcare ScienceRegulatory Authorities

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
  • Shape development plans and regulatory interactions across multiple regions
  • Align regulatory plans with Medicines Development Strategy and Integrated Asset Plan
  • Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval
  • Assess regulatory intelligence, precedents, and competitive landscape to inform strategy and improve 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
  • Minimum: Bachelor’s degree in biological, pharmaceutical or healthcare science
  • Proven experience in 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 for clarity and impact
  • Experience working effectively in matrix teams
  • Advanced scientific degree (PhD, MD, PharmD) is a plus
  • Proven ability in managing global and regional development, submission, and approval activities is a plus
  • Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints is a plus
  • Proficiency in digital fluency tools is a plus

Benefits

Comp & perks
  • Annual bonus may be offered
  • Eligibility to participate in a share based long term incentive program may be offered
  • Agile working culture and flexibility opportunities
  • Adjustments to the recruitment process available for candidates who require them