Manager - Regulatory Affairs Lifecycle Management - Medicines

Description Overview

We re excited to recruit a Manager as Medicines Lead for Lifecycle Management. You will play a key role in delivering Perrigo’s regulatory strategy across the medicines product lifecycle. You will lead the development and execution of post-approval regulatory strategies, ensuring the consistent delivery of high-quality regulatory outcomes across a diverse and complex medicines portfolio. 

You will be responsible for managing lifecycle management activities, overseeing the preparation, submission, and maintenance of regulatory dossiers and Marketing Authorisations in line with global requirements and business priorities. You will proactively identify risks, support mitigation planning, and ensure timely, compliant submissions that help maintain supply continuity, consumer and patient safety, and market access. 

Leading a team of multi-regional regulatory professionals, you will provide clear direction, support capability development, and foster a culture of accountability and continuous improvement. You will manage priorities across multiple activities, ensuring effective execution and alignment with departmental and organisational goals. 

Working closely with cross-functional stakeholders—including Quality, Safety, Supply Chain, and R&D—you will contribute regulatory expertise to change management and business initiatives. You will help translate regulatory requirements into practical, actionable plans that support product maintenance, compliance, and portfolio optimisation. 

You will also contribute to the continuous improvement of Regulatory Affairs processes and ways of working, helping to drive efficiency, consistency, and scalability across lifecycle activities. Through your role, you will support Perrigo’s ability to meet evolving regulatory requirements while maintaining high standards of compliance and quality. 

This role offers the opportunity to make a meaningful impact within the Regulatory Affairs organisation—supporting product availability and regulatory performance while developing your leadership and technical expertise in a dynamic, global environment. 

Scope of the Role

• Leads Lifecycle Management Regulatory Affairs for the assigned portfolio and is accountable for post-launch regulatory strategy, compliance performance, and delivery outcomes. 
• Sets direction, priorities, and governance to ensure compliant and timely execution of post-approval activities while balancing business needs, consumer or patient protection, and supply continuity. 
• Leads, develops, and performance-manages a team and shapes capability while driving a consistent One Regulatory Voice across the organisation.
• Owns governance and decision-making for post-approval changes across the medicines portfolio, including variations, renewals, PV-related regulatory commitments and reporting, maintenance and supply-driven changes, and regulatory intelligence-driven changes. 
• Establishes robust change control management with Quality, Supply Chain, and R&D and oversees impact assessments, submission strategy, implementation tracking, dossier integrity, inspection readiness, and metrics. 
• Acts as final decision-maker within delegated authorities for lifecycle change strategy, prioritisation, resourcing, and governance, escalating enterprise policy or high-risk precedent decisions as required.

Lifecycle Strategy, Governance & Delivery 

• Own post-launch regulatory strategy and compliance for the medicines portfolio, including variations, renewals, PV-related regulatory commitments and reporting, maintenance and supply-driven changes, and regulatory intelligence-driven changes. 
• Establish robust change control with Quality, Supply Chain, and R&D, ensuring impact assessments, submission strategy, implementation tracking, and inspection readiness are effective and sustainable. 
• Partner with Pharmacovigilance and Medical/Safety teams on safety-driven variations, product information updates, risk minimisation measures, PV-related regulatory commitments, and reporting requirements. 
• Ensure timely, compliant execution of lifecycle submissions and commitments; monitor performance and remove barriers to delivery. 

Risk, Authority Engagement & Portfolio Planning 

• Monitor and interpret regulatory trends and legislation; provide timely impact assessments and lead mitigation planning and CAPA governance to protect compliance and avoid supply disruption. 
• Lead authority interactions and escalations for lifecycle topics and represent Perrigo in local or cluster forums and trade associations where required. 
• Provide portfolio planning input for major changes, site transfers, cost optimisation, and portfolio optimisation or discontinuation decisions, ensuring regulatory feasibility and timelines are understood. 

Leadership, Capability & Operational Excellence 

• Lead and develop the team; set objectives, coach performance, build succession, and shape capability. 
• Drive harmonisation of SOPs and templates, oversee RIMS and workflow data quality, and use metrics to improve cycle times and accountability in partnership with RegOps. 
• Lead governance forums, escalation pathways, and cross-functional alignment so dossiers, decisions, and implementation requirements transition cleanly across Category, Cluster, and LCM interfaces. 

Experience Required

• Typically 8–10+ years in Regulatory Affairs with strong medicines lifecycle or post-launch compliance expertise, including knowledge of global medicines regulatory frameworks, post-approval variation requirements, CTD/eCTD dossier requirements, and lifecycle maintenance of Marketing Authorisations; relevant scientific or technical degree preferred. 
• Demonstrated people leadership, authority engagement, and experience managing competing priorities across a portfolio. 
• Experience working cross-functionally in a matrixed organization and providing strong regulatory writing and stakeholder management.