Sr Director of Regulatory Affairs - North America

Perrigo Sr Director of Regulatory Affairs - North America Location: Morristown, NJ, US, 07960 At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All . We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone , we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo . We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview As Senior 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. Office location preference is to be based out of Morristown, NJ with a hybrid working schedule. 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 elevate 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 labeling 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. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Target base salary range for NJ is $225 - $275K. Hybrid Working Approach We love our offices and the setting they provide for in‑person collaboration and celebration. But we also appreciate the opportunity to work remotely can energize you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #J-18808-Ljbffr Perrigo