Director of Regulatory Affairs North America - Regional Cluster Role

Trusted Consumer Self-Care Products•Morristown, TN

About The Position

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.

Requirements

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.

Responsibilities

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
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
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
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
Act as a 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
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
Act as the 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
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, and mitigation of safety-related regulatory risks
Ensure timely and accurate regulatory reporting and documentation related to vigilance obligations
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 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 organisation, promoting enterprise thinking and cross-functional collaboration across Regulatory, R&D, Commercial, Quality, and Medical