Manager – Regulatory Affairs Lifecycle Management – Medicines

Overview

You lead a global Medicines Lifecycle Management team to deliver post-approval regulatory strategy and ensure compliant, timely submissions across a diverse portfolio. You translate regulatory needs into practical plans, partnering with Quality, Safety, Supply Chain and R&D to maintain supply, safety and market access. Your leadership drives capability, governance, and cross-functional alignment for scalable lifecycle activities. This role offers impact in a dynamic, global regulatory environment and opportunities to grow your leadership and technical expertise.

Pay / Benefits

• Hybrid Working Approach
• Total Rewards
• competitive compensation
• career development opportunities

Responsibilities

• Lead post-launch regulatory strategy for the medicines portfolio, including variations, renewals, PV commitments and regulatory reporting
• Oversee change control with Quality, Supply Chain and R&D; manage impact assessments, submission strategy, tracking and inspection readiness
• Direct and develop a multi-regional regulatory team; drive One Regulatory Voice across the organization
• Partner with Pharmacovigilance and Medical/Safety on safety-driven variations and product information updates
• Ensure timely, compliant lifecycle submissions and monitor performance to remove delivery barriers
• Lead authority interactions and governance for lifecycle topics and regional forums as needed
• Contribute to portfolio planning, site transfers, cost optimization and lifecycle decisions with regulatory feasibility in mind
• Drive process harmonisation and data quality (RIMS) to improve cycle times and accountability
• Maintain governance, escalation pathways and cross-functional alignment across Category, Cluster and LCM interfaces

Key requirements

• Typically 8–10+ years in Regulatory Affairs with medicines lifecycle or post-launch compliance experience
• Strong knowledge of global medicines regulatory frameworks, post-approval variation requirements, CTD/eCTD and lifecycle maintenance of Marketing Authorisations
• Demonstrated people leadership and stakeholder management in a matrixed organization
• Experience with regulatory writing and cross-functional collaboration
• Ability to interpret regulatory trends and lead mitigation planning and CAPA governance

• leadership
• stakeholder management
• communication
• regulatory writing
• CTD/eCTD dossier management
• post-approval variations and renewals

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