GSK

Senior Manager, Regulatory Asset Oversight

GSK

full-time

Posted on:

Location Type: Hybrid

Location: WarsawPoland

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Salary

💰 PLN 198,000 - PLN 330,000 per year

Job Level

About the role

  • Partner with GRL and Regulatory Matrix Teams and Early/Medicine Development Teams.
  • Create and manage integrated regulatory plans.
  • Ensure the team is on track to deliver per the Regulatory strategy.
  • Collaborate across the R&D matrix for project management and submission oversight.
  • Facilitate submission delivery expectations.

Requirements

  • Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment.
  • 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.
  • Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.
  • Experience with project management and resource management systems, tools, & reporting features.
Benefits
  • Healthcare and wellbeing programmes
  • Pension plan membership
  • Shares and savings programme
  • Annual bonus based on company performance
  • Flexible working hours
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementregulatory strategysubmission oversightRegulatory Affairsdrug development
Soft Skills
collaborationcommunication