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GSK

Senior Manager, Regulatory Asset Oversight

GSK

. Partner with the Global Regulatory Lead and Regulatory Matrix Teams and Early/Medicine Development Teams .

Posted 11/12/2026full-timePoznan • PolandSenior💰 PLN 288,000 - PLN 480,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in regulatory affairs and project management within the pharmaceutical industry, with a strong focus on developing and executing integrated regulatory plans and strategies. Capable of leading multidisciplinary teams and ensuring alignment across various stakeholders while maintaining transparency and managing risks.

Highest-signal resume keywords
Regulatory Affairs ExperienceProject Management ExpertiseIntegrated Regulatory PlanningStakeholder EngagementRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory Asset OversightSubmission Delivery StrategiesScenario PlanningImpact AnalysesMetrics and KPIs ManagementResource ManagementDrug Development KnowledgeRegulatory Responsibilities KnowledgeProject Management SystemsOperational Execution
Soft Skills
Excellent Communication SkillsPersuasion and InfluenceConsensus BuildingTeam LeadershipProblem-Solving
Tools & Technologies
Regulatory TechnologiesProject Management ToolsReporting Features
Certifications & Qualifications
PMP Certification
Industry Keywords
Pharmaceutical IndustryDrug Development EnvironmentR&D ProcessesPre-INDPost-Approval

Tech Stack

Tools & technologies
PMP

About the role

Key responsibilities & impact
  • Partner with the Global Regulatory Lead and Regulatory Matrix Teams and Early/Medicine Development Teams
  • Provide overarching project management support to active Rx and Vx projects across the asset lifecycle
  • Create and manage integrated regulatory plans
  • Ensure teams remain on track to deliver according to regulatory strategy
  • Ensure consistent Regulatory Asset Oversight activities across project teams
  • Collaborate across the R&D matrix to align project management and submission oversight activities
  • Coordinate with Submission Delivery Excellence colleagues on operational execution
  • Lead within enterprise matrix teams including GRA, GRO, Clinical Operations, Data Management, and Stats and Programming
  • Develop and maintain a holistic global regulatory integrated plan at the asset level
  • Drive execution of plans through scenario planning, impact analyses, and risk mitigation
  • Assist RMTs and GRLs with submission delivery strategies aligned with R&D objectives
  • Align submission delivery strategy with the Global Submission Strategy throughout late-stage development
  • Serve as a single point of contact for RMT, Submission Coordination, and Publishing colleagues
  • Promote and drive use of integrated Regulatory technologies
  • Provide real-time submission status information through visuals and reports
  • Maintain metrics and KPIs for individual and team performance

Requirements

What you’ll need
  • Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment
  • 5 years of regulatory affairs experience or similar relevant project management experience
  • Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives
  • Strong project management expertise in the pharmaceutical industry or in a regulatory environment
  • Experience overseeing and prioritizing multiple activities across multiple assets
  • Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval
  • Experience with diverse stakeholders and multifaceted assets
  • Experience with project management and resource management systems, tools, and reporting features
  • Ability to effectively lead multidisciplinary team meetings and drive discussions regarding timelines, resource allocation, and risk management
  • Commutable distance to hubs in Mexico City, Mississauga, Ontario, Poznan, Poland, and Central London, UK
  • Training in project management skills/tools is a plus
  • PMP is a plus
  • Excellent written and verbal communication skills
  • Ability to present information clearly and concisely
  • Ability to interact across different levels in the regulatory organization and with external stakeholders
  • Ability to persuade and influence others to achieve team objectives
  • Ability to gain consensus in complex environments
  • Ability to identify and mitigate risks and bottlenecks
  • Ability to determine when to escalate issues
  • Ability to ensure transparency of project progress and status

Benefits

Comp & perks
  • Annual bonus based on company performance
  • Healthcare and wellbeing programmes
  • Pension plan membership
  • Shares and savings programme
  • Hybrid working model through Performance with Choice
  • Competitive salary
  • Eligibility to participate in a share based long term incentive program
  • Equal opportunity employment
  • Disability accommodations during the application process