Associate Director - Regulatory Affairs Operations

Description Overview

We are excited to recuit a new Associate Director - Regulatory Affairs Operations to join Perrigo Scientific Office. 

As the Operations lead, you will play a key role in delivering Perrigo’s enterprise regulatory systems, publishing digitialisation/data, process, and metrics across the product lifecycle. You will lead the development and execution of regulatory strategies for regulatory operating models, systems programs and transofrmation into digitialisation environment as part of the function's day to day activities. You will be ensuring the consistent delivery of high-quality regulatory outcomes across a diverse and complex portfolio of classifications and markets. Working closely with all RA teams and cross-functional stakeholders—including Quality, IT, Supply Operations, R&D—you will contribute regulatory expertise to change management and business initiatives. 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 organisatio - supporting product availability and regulatory performance while developing your leadership and technical expertise in a dynamic, global environment.

Scope of the Role

• Own enterprise governance and decision-making including regulatory platforms, publishing/submission standards, data governance, document and records management, workflow design, metrics, and operational support for lifecycle submissions, commitments, and major business change
• Define and maintain global operating model/interfaces across LCM, Category, Cluster, Quality, Supply Chain, R&D, IT  to ensure data integrity, compliant execution, efficient implementation of regulatory change, and clear accountability
• Final decision-maker within delegated authorities for strategy, capability roadmap, standards, process design, system priorities, investment recommendations, and operational governance, escalating enterprise policy, significant risk, or precedent-setting decisions as required
• Provide team direction, support development, foster culture of accountability/continuous improvement
• Manage priorities across multiple activities, ensure effective execution and alignment with department/ organisation goals
• Manage central publishing of CTD dossiers in line with business priorities across the full product lifecycle.Develop regulatory system programs and roadmaps
• Develop and maintain operating model ensuring consistent approach 

Enterprise Regulatory Operations Strategy, Governance & Delivery

• Own enterprise Regulatory Operations strategy and roadmap for systems, publishing, document management, regulatory data, workflow controls, and service delivery supporting the full product lifecycle
  Lead on design, implementation, and governance of global processes and platforms to ensure compliant, efficient, and scalable execution of submissions, post-approval activity, authority commitments, and regulatory change
  Establish clear governance, prioritisation, and performance management for activities, ensuring delivery risks are visible, resolved, and escalated appropriately
  Provide strategic leadership to Regulatory Affairs leadership teams on operational readiness, organisational scalability, and the regulatory implications of business transformation, portfolio change, and market expansion.

Digital Data & Compliance Leadership

• Define and lead the enterprise roadmap for regulatory systems, structured data, reporting, and automation to support evolving external requirements, stronger insight generation, and efficient regulatory execution
• Monitor and interpret evolving external regulatory data and submission requirements, including SPOR, IDMP, IRIS, and related regional standards; translate these into business impacts, capability needs, and implementation plans
• Set and enforce data governance, control standards, quality expectations, and inspection-readiness requirements for regulatory information, ensuring traceability, consistency, and sustainable compliance across the organisation
• Lead vendor, platform, and process optimisation decisions that improve user adoption, data quality, submission quality, cycle times, and organisational visibility through meaningful metrics and dashboards

Leadership, Capability & Operational Excellence

• Lead/develop organisation set vision and objectives, coach senior leads, build succession and shape capability in operations, systems, publishing, data governance,digital transformation
• Drive harmonisation of SOPs, templates, roles, governance forums, and ways of working, and embed a culture of accountability, continuous improvement, and operational excellence
• Lead cross-functional governance, escalation pathways, and business change initiatives so operational requirements, regulatory decisions, and implementation needs transition cleanly across Category, Cluster, and LCM interfaces and with external partners where relevant

Experience Required

• Relevant senior level experience in Regulatory Affairs with significant leadership experience in Regulatory Operations, regulatory systems, publishing, regulatory data management, or adjacent operational leadership roles, and relevant scientific or technical degree preferred.
• Demonstrated leadership of managers and/or complex matrixed teams, with experience setting enterprise strategy, influencing senior stakeholders, and leading transformation across functions, geographies, and product classifications.
• Strong experience with regulatory systems, structured data standards, operational compliance requirements, and business case development, with the ability to translate complex requirements into scalable operating models and investment priorities.

Demonstrated areas of expertise:

• Enterprise Regulatory Leadership: Sets enterprise direction and ensures a consistent, future-ready Regulatory Operations approach aligned to One Regulatory Voice and business priorities.
• Organisational Leadership: Builds and leads high-performing teams and leaders through coaching, talent development, succession planning, and clear accountability.
• Strategic Execution: Translates strategy into operating models, governance, investment choices, capability roadmaps, and measurable outcomes and drives continuous improvement.
• Decision-Making & Accountability: Makes risk-based decisions balancing compliance, data integrity, speed, efficiency, inspection readiness, and business continuity.
• Stakeholder Partnership: Acts as a strategic partner to senior leaders and leads cross-functional alignment and escalations on systems, data, process, and operating model change.
• Risk & Compliance Ownership: Accountable for enterprise compliance outcomes in Regulatory Operations, including data quality, submission standards, records integrity, audit and inspection readiness, and prevention of execution risk.
• External Awareness & Influence: Monitors regulatory operations trends and represents the organisation in relevant external associations, consultations, vendor partnerships, or industry forums where appropriate.