Associate Director, Global Submission Management
London, United Kingdom
Contract
Posted 1 hour ago
Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
About the Role:
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
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.