Associate Director, Global Submission Management
London, United Kingdom
Contract
Posted 2 weeks ago
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
- 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
- Bachelor’s degree in life sciences or technology-related field
- Regulatory/clinical project management experience in a life sciences company
- Supervisory/management experience