Global Regulatory Associate Director, Life Cycle Management

Overview

In this role you drive regulatory strategy for a complex portfolio to secure timely access to medicines. You will collaborate with cross-functional teams and health authorities to shape submissions and responses, improving processes and mentorship within a global regulatory environment. The position offers impact at scale, contributing to patient outcomes and the company’s mission to reimagine medicine. You will engage in meaningful, global regulatory work and continuous improvement initiatives.

Pay / Benefits

• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs
• flexible and hybrid working options
• paid parental leave

Responsibilities

• Independently manage regulatory maintenance activities for a high-complexity product portfolio
• Ensure timely, compliant preparation and submission of regulatory maintenance deliverables
• Provide strategic regulatory input to cross-functional deliverables, including safety reports, variations, and renewals
• Act as liaison with health authorities for complex regulatory matters
• Identify risks, gaps, and trade-offs to support timely approvals and minimise delays
• Lead responses to health authority queries with robust scientific justifications
• Contribute to continuous improvement initiatives and mentor junior associates

Key requirements

• Bachelor’s or Master’s degree in a scientific discipline or equivalent experience
• Significant experience in regulatory maintenance activities and regulatory processes in the pharmaceutical industry
• Proven knowledge of global regulatory submission and approval processes across major regions
• Experience in planning, execution, regulatory review, and compliance of submissions
• Ability to interpret safety and efficacy data and product labelling requirements
• Strong communication skills with a proactive, accurate, stakeholder-focused approach
• Demonstrated ability to work effectively in cross-functional, global matrix environments
• Experience contributing to process improvements, simplification, or operational excellence initiatives

• Strong communication
• Stakeholder-focused
• Cross-functional collaboration
• Regulatory compliance
• Risk management
• Clinical trials

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