Sr Director of Regulatory Affairs
Listed on 2026-08-19
-
Business
Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist
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 OverviewAs 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
- 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
- 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
- Primar…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).