Senior Professional Regulatory Affairs - Lifecycle Management - Medicines

At Perrigo, we are driven by our mission to make lives better through trusted health and wellness solutions, accessible to all. We are a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over-the-counter and infant formula products. Dedicated to providing the best self-care for everyone, we are the people behind brands you trust, including Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more.

About the role

We are recruiting a Senior Professional within the Medicines classification team for Lifecycle Management. In this role, 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 consistent delivery of high-quality regulatory outcomes across a diverse and complex portfolio.

You will manage lifecycle management activities, overseeing the preparation, submission, and maintenance of approved applications and regulatory dossiers in line with FDA requirements, relevant ICH expectations, other applicable health authority 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.

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 organizational 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.

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

Responsibilities

• Lead complex, high-impact lifecycle regulatory projects and workstreams across multiple drug products, the US market, and/or global markets, or regulatory pathways.
• Provide strategic regulatory leadership for significant post-approval supplements and annual reportable changes, remediation, and compliance risks, ensuring lifecycle delivery protects compliance posture, approved application commitments, and supply continuity.
• Act as a recognized subject matter expert, mentor others, and drive governance and continuous improvement within the Lifecycle Management (LCM) team.
• Lead complex change programs such as site transfers, CMC and quality-related post-approval changes, renewals, remediation, or other high-risk lifecycle activities for NDA, ANDA, OTC monograph, and/or related drug product portfolios.
• Lead assessment and management of complex and high-risk post-approval changes across the US market and/or global markets, defining data needs, appropriate FDA reporting category, submission strategy, and dossier updates.
• Provide strategic oversight of lifecycle dossiers, technical documentation, and inspection readiness; set and coach high standards for right-first-time quality.
• Lead complex lifecycle submissions across products and markets, including post-approval supplements, annual reportable changes, renewals, remediation, escalated RFIs, and deficiency responses.
• Approve or recommend change approach, appropriate FDA reporting category, and submission strategy within delegated remit, and escalate major compliance or supply risks through governance.
• Anticipate and mitigate significant regulatory risks and lead issue resolution for compliance gaps or supply disruption threats.
• Lead cross-functional risk reviews, remediation planning, and governance forums with Quality, Supply, Safety, R&D, Manufacturing, RegOps, and Cluster RA.
• Drive cross-functional improvements to lifecycle processes and systems, define implementation steps, and embed standard work.
• Act as regulatory lead for complex health authority interactions, including FDA as applicable, and coordinate consistent evidence-based responses.
• Coach and quality review the work of colleagues and embed Good Documentation Practice within the team.
• Influence senior stakeholders and cross-functional teams without formal authority to achieve aligned decisions and timely delivery.

Requirements

• Typically 5–8+ years in Regulatory Affairs with proven experience leading complex regulatory projects and authority interactions.
• Relevant scientific or technical degree preferred.
• Sustained performance in complex lifecycle roles or similar experience considered.
• Demonstrated capability in strategic lifecycle thinking, governance, and coaching others.

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo.

Schedule

We promote flexibility with the ability to work two days a week from home in many roles.