Associate Director, Global Submission Management
Location: Hybrid (Paddington – 3 days in office) OR Remote
Contract: 14 months
Department: Regulatory Operations
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
Why Join Us?
This is an exciting opportunity to play a pivotal role in regulatory submission management for a global pharmaceutical’s organisation.
If you’re a detail-oriented leader with a passion for driving successful regulatory strategies, we’d love to hear from you!