Perrigo
Assistant Professional Regulatory Affairs - Regulatory Operations
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Description Overview
We are excited to recruit an Assistant Professional Regulatory Affairs - Regulatory Operations. In this role you will support Perrigo’s regulatory publishing and submission delivery activities, helping to ensure that regulatory submissions and related operational outputs are prepared accurately, consistently and in line with agreed timelines.
You will assist with publishing preparation, document readiness, submission package compilation, tracking and quality checks across products, markets and regulatory workstreams. Working as part of the Regulatory Operations team, you will help ensure documents, records and submission components are complete, traceable and managed in line with applicable regulatory requirements, internal standards and business priorities.
You will support a range of regulatory operations activities, including publishing administration, document workflow support, submission planning, tracker maintenance and implementation follow-up. Through close collaboration with Regulatory Affairs colleagues, you will help identify missing information, escalate issues promptly and contribute to timely submission delivery.
Working with stakeholders across Lifecycle Management, Category Regulatory Affairs, Cluster Regulatory Affairs, Quality, Safety, Supply Chain, Artwork, IT and other relevant functions, you will provide operational support to help ensure submission packages are prepared and delivered to the required quality and compliance standards.
You will contribute to continuous improvement of Regulatory Operations processes, systems and ways of working, helping to improve efficiency, consistency, data quality and right-first-time delivery across publishing and submission activities. Through your role, you will build foundational knowledge of regulatory publishing, document management, submission standards and regulatory systems.
This role offers an excellent opportunity to begin or further develop a career in Regulatory Operations, building practical publishing, submission delivery, systems and process capability while supporting Perrigo’s commitment to compliant, timely and high-quality regulatory delivery.
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Scope of the Role
- Supports compliant and timely regulatory publishing and submission delivery by contributing to document readiness, publishing preparation, submission package compilation, tracker maintenance and quality checks across products and markets.
- Provides an entry point into Regulatory Operations for either a graduate building foundational regulatory operations capability or an experienced administrator/coordinator moving into a regulatory publishing and submission delivery career pathway.
- Builds practical understanding of regulatory publishing, document workflows, submission standards and regulatory systems while operating with agility across changing priorities and supporting a flexible work remit in line with business needs.
- Supports regulatory publishing and submission delivery activities within Regulatory Operations under the direction of more experienced regulatory operations colleagues.
- Works across document readiness, publishing preparation, submission trackers, quality checks, records management and basic implementation support for defined products, markets or workstreams.
- Contributes within project and submission teams with no people leadership and increasing exposure to regulatory product types, markets, submission formats, document workflows and regulatory systems.
Publishing Delivery Support
- Support preparation, compilation and maintenance of regulatory publishing documentation, submission packages, trackers and related operational records.
- Assist with submission planning and tracking for regulatory submissions, lifecycle activities, renewals, notifications and related maintenance activities.
- Gather, organise and check source information required to support document readiness, publishing preparation, submission compilation and implementation activities.
- Contribute to accurate tracking of submission status, publishing deliverables and implementation activities to help protect compliance, timelines and continuity of supply.
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Compliance, Documentation & Process Discipline
- Maintain records and documentation in line with Good Documentation Practice, regulatory operations processes and established quality standards.
- Support routine document formatting, file management, quality checks and submission readiness activities under guidance.
- Escalate and follow up on missing information, documentation gaps, quality issues, system issues or delivery risks promptly and accurately.
- Contribute to disciplined handover and transition of submission information, decisions, files and records across Regulatory Affairs and cross-functional interfaces.
Learning, Collaboration & Ways of Working
- Build understanding of regulatory publishing processes, submission standards, document workflows, regulatory systems and terminology across products and markets.
- Work effectively with Regulatory Affairs Operations, Lifecycle Management, Category and Cluster teams as well as with Quality, Safety, R&D, Supply, Artwork, IT and other relevant colleagues.
- Demonstrate flexibility to support a range of administrative, coordination, document management and entry-level regulatory operations activities depending on business priorities.
Experience Required
- Degree in Life Sciences, Regulatory Affairs, Information Management, Business Administration or a related discipline, or relevant administrative/co-ordination experience in a regulated, quality-driven or document-intensive environment.
- Entry level role for people with up to 2 years’ experience in Regulatory Affairs, Regulatory Operations, publishing, document management, data management or a related operational environment.
- Strong organisational skills, attention to detail and the ability to manage documents, data and information accurately in a structured environment.
- Demonstrated ability to work collaboratively, learn quickly and follow established processes and quality standards.
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