Associate Director, Global Submission Management

London, United Kingdom

Contract

Posted 2 weeks ago

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About the Role:
We are seeking an experienced Associate Director, Global Submission
Management to join our Regulatory Operations team.
This role is crucial in managing and tracking a portfolio of global
regulatory submissions across multiple programs.
You will drive comprehensive planning, ensuring all major milestones
are met while proactively identifying and mitigating risks.
As a key leader, you will oversee project and portfolio plans, guide
submission strategies, and support the broader Global Regulatory
Affairs (GRA) team in achieving successful regulatory filings.

Key Responsibilities:

  • Lead complex regulatory submission projects from initiation to completion
  • Define project milestones, dependencies, and resource needs
  • Develop and maintain project plans, status reports, and risk mitigation strategies
  • Identify and resolve project issues, ensuring timely submissions
  • Communicate project updates to stakeholders and leadership teams
  • Manage and mentor members of the submission management team
  • Provide data-driven insights to support resource, budget, and strategic discussions
What We’re Looking For:
  • Expertise in global regulatory filing project management
  • Strong knowledge of global health authority submission requirements
  • Proficiency in project management tools
  • Excellent organisational, communication, and stakeholder management skills
  • Ability to drive deadlines and adapt to evolving priorities
  • Previous experience leading teams in a regulatory or clinical setting
Qualifications & Experience:
  • Bachelor’s degree in life sciences or technology-related field
  • Regulatory/clinical project management experience in a life sciences company
  • Supervisory/management experience