Senior Manager Regulatory Affairs Lifecycle Management Medical Devices

Description Overview

We are excited to recruit a Senior Manager Regulatory Affairs Lifecycle Management Medical Devices. This is a newly created role within Perrigo's Scientific Office.

As Medical devices Lead for LCM you will play a key role in delivering Perrigo’s regulatory strategy across the product lifecycle. You will support the development and execution of regulatory strategies, ensuring the consistent delivery of high-quality regulatory outcomes across a diverse and complex portfolio.

You will be responsible for managing lifecycle management activities, overseeing the preparation, submission, and maintenance of regulatory dossiers 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 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

• Own regulatory delivery for a defined portfolio or programme across Lifecycle Management and Regulatory Operations interfaces.
• Ensures right-first-time submissions, compliant implementation, and robust integration of lifecycle management and operational execution.
• Acts as senior advisor and escalation point for regulatory risks, leading a team or matrix workstreams while shaping strategy for higher-complexity lifecycle topics.
  Independently assesses and manages complex post-approval changes, renewals, label updates, and implementation controls across the assigned portfolio or programme.
• Leads preparation or review of change documentation and response packages under governance and ensures submission publishing readiness, document management, and data integrity.
• Owns end-to-end delivery within governance for multi-product portfolio scope with measurable lifecycle and operational outcomes.

Lifecycle & Operational Delivery

• Manage post-approval changes, variations, renewals, labels, and implementation controls across the portfolio or programme.
• Provide regulatory leadership for relevant changes and responses under governance, ensuring dossier integrity and alignment with lifecycle commitments.
• Ensure submission publishing readiness, document control, and system or data integrity in partnership with Regulatory Operations.
• Use dashboards, trackers, and metrics to manage workload, cycle times, right-first-time quality, and implementation performance.

Strategy, Governance & Risk

• Own regulatory delivery plans, priorities, and risk escalation within scope; approve submission readiness and escalate novel or high-risk issues and major supply or portfolio risks.
• Drive process simplification, digital enablement, and continuous improvement across lifecycle and operational delivery.
• Ensure disciplined handovers between Category, Cluster, and LCM/Ops and maintain One Regulatory Voice and implementation tracking.

Leadership & Partnership

• Lead cross-functional workstreams and develop capability through coaching and matrix leadership.
• Partner with Quality, Safety, R&D, Supply Chain, Manufacturing, Artwork, IT/Data, vendors, and Cluster/Category RA to ensure timely, compliant implementation.

Experience Required

• Bachelor’s degree or higher in Life Sciences, Pharmacy, or related discipline.
• Significant relevant experience in Regulatory Affairs with proven submission and lifecycle delivery; people leadership experience preferred.
• Strong regulatory writing, stakeholder management, and operational delivery leadership.

Demonstrated areas of expertise:

• Regulatory Expertise & Judgement: Applies sound regulatory and scientific knowledge across classifications and geographies and interprets requirements pragmatically.
• Execution Excellence: Plans and delivers end-to-end activities to quality and timelines and drives right-first-time.
• Strategic Thinking: Evaluates options and documents rationale and anticipates downstream lifecycle and operational impacts.
• Leadership & Collaboration: Leads teams and influences in a matrix, coaches others, and builds capability.
• Communication & Influence: Communicates risks and recommendations clearly to senior stakeholders and external partners.
• Risk & Compliance Mindset: Proactively identifies and mitigates risks, supports CAPA, and protects continuity of supply.
• Continuous Improvement: Improves processes, tools, and ways of working and uses metrics to drive performance.