Associate Director, Global Submission Management

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!