Sr Director of Regulatory Affairs - North America
Perrigo Company plc
August 22, 2026
Remote friendly (Morristown, NJ)
United States
Corporate Functions
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, translating Category Regulatory strategy into effective local execution to ensure compliant, timely approvals and enable business growth.
Role Responsibilities
- Define and lead regional regulatory execution priorities aligned to Category strategies; enablement partner to the Commercial Cluster Lead team.
- Translate Category regulatory strategies into actionable market execution plans with market insight and regulatory intelligence.
- Lead engagement with FDA and Health Canada.
- Collaborate with regional commercial, medical, quality, and policy teams to support business growth.
- Own cluster regulatory delivery performance and set submission priorities aligned to commercial objectives.
- Partner with LCM & Reg Ops to execute post-launch lifecycle activities.
- Maintain relationships with health authorities; represent the company in regional industry associations and policy forums.
- Provide strategic input on regulatory trends, policy developments, and external risks to Category RA and enterprise governance.
- Support innovation pipelines; lead in-market regulatory execution for innovation.
- Provide feasibility, regulatory pathway implications, and timing assessments for portfolio decisions and launch planning.
- Support business development, licensing, and M&A activities.
- Ensure compliance with applicable regulatory requirements; own the cluster regulatory risk register.
- Lead inspection readiness and regulatory response; primary escalation point for regulatory risks.
- Ensure vigilance compliance and timely, accurate regulatory reporting/documentation.
- Lead, develop, and inspire the cluster regulatory team; drive alignment across Regulatory pillars.
Qualifications
- Degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field.
- 15+ years progressive regulatory affairs experience in consumer health/pharmaceuticals/adjacent sectors.
- Demonstrated experience leading regulatory strategy execution and delivery at market/regional level, including health authority interactions.
- Strong North America regulatory framework experience (FDA and/or Health Canada).
- Proven ability to act as primary regulatory interface for complex submissions, negotiations, and issue resolution.
- Strong business acumen partnering with commercial and cross-functional stakeholders.
Benefits
- Target base salary range for NJ: $225–$275K.
Application Instructions
- Click the APPLY button at the bottom of the application.
- All application materials (resumes/CVs) must be submitted in English.
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, translating Category Regulatory strategy into effective local execution to ensure compliant, timely approvals and enable business growth.
Role Responsibilities
- Define and lead regional regulatory execution priorities aligned to Category strategies; enablement partner to the Commercial Cluster Lead team.
- Translate Category regulatory strategies into actionable market execution plans with market insight and regulatory intelligence.
- Lead engagement with FDA and Health Canada.
- Collaborate with regional commercial, medical, quality, and policy teams to support business growth.
- Own cluster regulatory delivery performance and set submission priorities aligned to commercial objectives.
- Partner with LCM & Reg Ops to execute post-launch lifecycle activities.
- Maintain relationships with health authorities; represent the company in regional industry associations and policy forums.
- Provide strategic input on regulatory trends, policy developments, and external risks to Category RA and enterprise governance.
- Support innovation pipelines; lead in-market regulatory execution for innovation.
- Provide feasibility, regulatory pathway implications, and timing assessments for portfolio decisions and launch planning.
- Support business development, licensing, and M&A activities.
- Ensure compliance with applicable regulatory requirements; own the cluster regulatory risk register.
- Lead inspection readiness and regulatory response; primary escalation point for regulatory risks.
- Ensure vigilance compliance and timely, accurate regulatory reporting/documentation.
- Lead, develop, and inspire the cluster regulatory team; drive alignment across Regulatory pillars.
Qualifications
- Degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field.
- 15+ years progressive regulatory affairs experience in consumer health/pharmaceuticals/adjacent sectors.
- Demonstrated experience leading regulatory strategy execution and delivery at market/regional level, including health authority interactions.
- Strong North America regulatory framework experience (FDA and/or Health Canada).
- Proven ability to act as primary regulatory interface for complex submissions, negotiations, and issue resolution.
- Strong business acumen partnering with commercial and cross-functional stakeholders.
Benefits
- Target base salary range for NJ: $225–$275K.
Application Instructions
- Click the APPLY button at the bottom of the application.
- All application materials (resumes/CVs) must be submitted in English.