Senior Professional Regulatory Affairs -Lifecycle Management - Regulatory Operations

Description Overview

We are excited to recruit a Senior Regulatory Affairs Professional within Regulatory Operations, you will play a key role in coordinating and managing regulatory publishing activities across Perrigo’s portfolio, helping to ensure high-quality, compliant and timely delivery of submissions and related regulatory operational outputs.

You will be responsible for supporting and coordinating publishing planning, submission readiness, document workflows and operational delivery activities, working closely with Regulatory Affairs colleagues across Lifecycle Management, Category, Cluster and other cross-functional partners. You will help ensure that submission packages are prepared, quality checked and delivered in line with applicable regulatory requirements, internal standards and business priorities.

This role will also support the development and improvement of regulatory operations processes, systems and metrics. You will contribute to the optimisation of ways of working, support data and process quality, and help embed consistent, scalable approaches across Regulatory Affairs. You will work with stakeholders to identify operational risks, resolve delivery barriers and support timely execution of regulatory activities.

Acting as a senior professional within the Regulatory Operations team, you will provide technical expertise, coordination support and guidance to others. You will help drive operational discipline, right-first-time quality and continuous improvement across publishing, process, systems and performance management activities.

This role offers the opportunity to make a meaningful impact within the Regulatory Affairs organisation by supporting compliant regulatory delivery, improving operational ways of working and helping Perrigo build more digitally enabled, data-led and scalable regulatory operations capability.

Scope of the Role

• Leads and coordinates regulatory publishing and operational delivery activities across multiple products, markets and regulatory workstreams.
• Provides expertise in publishing coordination, submission readiness, document management, regulatory systems, process improvement and operational metrics. Acts as a senior Regulatory Operations professional, supporting governance, continuous improvement and consistent ways of working.
• Leads publishing activities supporting regulatory submissions, lifecycle management, commitments and business priorities. Operates with a high degree of autonomy, accountable for recommendations, issue resolution and technical guidance within delegated authority.
• Acts as a senior individual contributor and mentor, supporting delivery across publishing, systems, document management, process improvement and metrics. Collaborates closely with Lifecycle Management, Category and Cluster Regulatory Affairs, Quality, Supply Chain, Safety, IT and other stakeholders to ensure compliant, timely and efficient operations.
• Provides support across broader regulatory activities as business needs require.

Publishing Coordination & Operational Delivery

• Lead and coordinate publishing activities for regulatory submissions across medicinal products and global markets, ensuring quality, compliance and timely delivery.
• Manage submission readiness, including planning, document tracking, quality reviews, dependency management and issue resolution.
• Partner with Regulatory Affairs and cross-functional teams to ensure submission packages are complete, accurate and compliant.
• Support execution of regulatory commitments and operational deliverables, escalating risks where required.
• Provide technical guidance on publishing standards, document workflows, operational processes and submission requirements.
• Coordinate and guide matrixed publishing resources supporting portfolio and project delivery.

Process, Systems & Metrics

• Support implementation, optimisation and governance of Regulatory Operations processes, systems and workflows.
• Contribute to standard procedures, templates, controls and ways of working that improve efficiency, consistency and scalability.
• Support regulatory data quality, document management and effective system use.
• Develop and monitor operational metrics covering delivery performance, quality, compliance, workload and cycle times.
• Identify improvement opportunities and translate operational insights into sustainable solutions.

Governance, Compliance & Continuous Improvement

• Anticipate and mitigate risks related to publishing, submission readiness, data integrity, compliance and delivery timelines.
• Support governance forums, escalations and business change initiatives to ensure effective implementation of operational requirements.
• Promote inspection-ready, compliant and traceable practices across Regulatory Operations.
• Drive continuous improvement initiatives that enhance publishing quality, process efficiency, reporting and system adoption.
• Coach and review the work of colleagues, reinforcing Good Documentation Practice and right-first-time principles.
• Act as a subject matter expert on regulatory publishing, evolving submission requirements and industry expectations, partnering with data, digital and systems teams to improve efficiency, data integrity and scalable publishing capability.

Experience Required

• Typically 5–8+ years in a healthcare company or similar sector for Regulatory Affairs, Regulatory Operations, publishing, regulatory systems, document management, regulatory data management or related operational roles; relevant scientific, technical or regulatory degree preferred.
• Proven experience coordinating or leading regulatory publishing, submission readiness, operational delivery or process improvement activities across multiple products, markets or workstreams.
• Demonstrated capability in regulatory operations execution, stakeholder coordination, issue resolution, governance and continuous improvement.
• Experience working with regulatory systems, publishing tools, document workflows, submission standards, operational metrics or regulatory data processes.
• Ability to translate operational requirements into practical plans, clear processes and business-ready solutions.
• Strong communication, organisation and stakeholder management skills, with the ability to influence across a matrixed environment.