Senior Manager, Regulatory Affairs NA Cluster

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• Senior Manager, Regulatory Affairs NA Cluster
• Location: Allegan, MI, US, 49010

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Description Overview

As Senior Manager 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 support Head of Cluster to 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 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 Allegan, MI or Morristown, NJ with a hybrid working schedule.

Scope of the Role

Cluster Regulatory

Define and lead the regional regulatory execution priorities, aligned to Category strategies - representing the function on the Commercial Cluster multifunctional 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

Support Cluster Head to 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

Responsible for 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

Support inspection readiness and regulatory response

Maintains local trackers; monitors regulatory changes; advises business on local impact and mitigations.

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 project management regulatory team aligned with Perrigo core values and behaviors

Build and strengthen capability in health authority engagement, regulatory execution, and business partnering

Support 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 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.
• 12+ years of progressive regulatory affairs experience within consumer health or pharmaceuticals.
• 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.

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• Total Rewards at Perrigo.

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 energise 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".

Applicants please note

• To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.)
• All application materials, including resumes and CVs, must be submitted in English.
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