Director of Regulatory Affairs - North America

Description Overview

As Director of Regulatory Affairs - Cluster (North America), you are accountable for in-market regulatory activation, execution, and health authority engagement across the cluster. You translate Category Regulatory strategies into effective local execution, ensuring compliant, timely approvals and enabling business growth across North America.

You act as the primary regulatory interface to health authorities (e.g., FDA and Health Canada), and as a strategic partner to in-market commercial teams. You are accountable for regulatory delivery performance, market risk management, and submission readiness, working in partnership with Category Regulatory Affairs and LCM & Regulatory Operations.

 

This role sits within the Cluster Regulatory Affairs pillar, accountable for in-market execution and regulatory delivery. Category Regulatory Affairs owns ideation-to-launch strategy, regulatory pathways, and global dossier expectations; this role provides market input and executes the agreed strategy locally. LCM & Regulatory Operations owns regulatory classification governance, post-launch lifecycle activities (non-innovation), and operational processes and systems; this role sets market priorities and delivery expectations. Final submission sign-off is owned by Markets in partnership with Category Regulatory Affairs; this role leads readiness, execution, and regulatory recommendation.

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 prioritie 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 behaviours
• Build and strengthen capability in health authority engagement, regulatory execution, and bus