Director of Regulatory Affairs

Scope of the Role
Cluster Regulatory Leadership

Define and lead the regional regulatory execution priorities, aligned to Category strategies – representing the function on the Commercial Cluster Lead team and being a business enabling partner at Cluster level
Translate Category regulatory strategies into actionable market execution plans, providing key market insight and regulatory intelligence
Lead engagement with FDA and Health Canada
Collaborate with regional commercial, medical, quality, and policy teams to ensure regulatory execution supports business growth and market competitiveness
Regulatory Operations & Lifecycle Management

Own cluster regulatory delivery performance and set submission priorities aligned to commercial objectives
Partner with LCM & Reg Ops ensuring effective execution of post-launch lifecycle activities
Health Authority Engagement & Policy Influence

Maintain relationships with health authorities across the cluster, representing Perrigo in regional industry associations and policy forums
Provide strategic input to Category Regulatory Affairs and enterprise governance on regulatory trends, policy developments, and external risks
Innovation Enablement & Business Growth

Partner with Category Regulatory team to support innovation pipelines. Lead in-market regulatory execution for innovation
Provide market-specific feasibility, regulatory pathway implications, and timing assessments to inform portfolio decisions and launch planning
Regulatory business partner to commercial teams
Support business development, licensing, and M&A activities
Identify opportunities to optimize regulatory pathways, accelerate approvals, and enable competitive advantage
Compliance, Governance & Risk Management

Ensure compliance with all applicable regulatory requirements at the market level within the cluster
Own cluster regulatory risk register
Lead inspection readiness and regulatory response
Primary escalation point for regulatory risks and escalate to Category RA governance for alignment and decision-making
Embed regulatory intelligence into business planning and decision-making
Ensure appropriate regulatory governance is applied to submissions, claims, and labelling decisions
Regional Vigilance

Accountable for regulatory vigilance compliance delivered in partnership with Global Patient Safety
Ensure inspection and audit readiness for vigilance-related regulatory requirements
Provide regulatory oversight to ensure alignment between local market requirements and global vigilance frameworks
Support identification, assessment, mitigation of safety-related regulatory risks
Ensure timely and accurate regulatory reporting and documentation related to vigilance obligations
Team Leadership & Capability Building

Lead, develop, and inspire high-performing cluster regulatory team aligned with Perrigo core values and behaviors
Build and strengthen capability in health authority engagement, regulatory execution, and business partnering
Drive alignment and ways of working across Cluster Regulatory Affairs, Category Regulatory Affairs, and LCM & Regulatory Operations, ensuring clarity of roles, responsibilities, and decision-making
Act as a strategic leader and role model within the organization, promoting enterprise thinking and cross-functional collaboration across Regulatory, R&D, Commercial, Quality, and Medical
Experience Required
Degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field.
15+ years of progressive regulatory affairs experience within consumer health, pharmaceuticals, or adjacent sectors.
Demonstrated experience in leading regulatory strategy execution and delivery at market or regional level, including health authority interactions.
Strong experience with North America regulatory frameworks (e.g., FDA and/or Health Canada), or equivalent regional expertise where applicable.
Proven ability to act as the primary regulatory interface with health authorities, including managing complex submissions, negotiations, and issue resolution.
Strong business acumen with the ability to partner effectively with commercial and cross-functional stakeholders to enable growth.