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