Senior Director, Regulatory Affairs - CMC, Regulatory Operations & Lifecycle Management

Description Overview

As Senior Director, you will serve as the visionary leader shaping Perrigo’s global regulatory future. You will champion the development and execution of cutting-edge Chemistry, Manufacturing & Control (CMC) strategies, ensuring the highest standards of regulatory excellence across our diverse portfolio—from pharmaceuticals and medical devices to supplements, cosmetics, and beyond.

Your influence will drive the creation of robust quality dossiers and the seamless navigation of regulatory landscapes, turning challenges into opportunities for innovation and growth. By orchestrating timely submissions and proactively identifying risks and mitigation plans, you'll secure first-to-market approvals that enhance Perrigo’s reputation as a global leader in regulatory affairs.

You will inspire and empower a high-performing regulatory team, instilling a culture of agility, compliance, and continuous improvement. With your strategic insight, you will oversee lifecycle maintenance, safeguarding the ongoing compliance and success of all Perrigo products. Your leadership in regulatory operations will build a resilient framework—one that streamlines processes and advances organizational excellence.

As a pivotal member of the Regulatory Affairs leadership team, your stewardship will extend beyond the company, shaping regulatory policy and advocating best practices on the world stage. Through your foresight and collaboration, you will optimize Perrigo’s portfolio, position the organization for enduring success, and uphold our mission to advance consumer health worldwide. Your legacy will be one of transformative impact, setting new standards for regulatory leadership and inspiring those around you to achieve greatness.

Scope of the Role

CMC Regulatory Strategy

• Lead global CMC regulatory strategy and execution for innovation, post-approval changes, lifecycle management, and compliance across all product categories.
• Oversee preparation and submission of high-quality CMC documentation (e.g., Module 3, QOS) for global health authority filings, including MAAs/NDAs/ANDAs, variations, renewals, and compliance updates.
• Develop response strategies for CMC-related regulatory queries and deficiency letters.
• Manage complex CMC projects (e.g., tech transfers, major reformulations, geo-expansion).
• Monitor global CMC regulatory trends; assess product impact and guide compliance strategies in partnership with Regulatory Product Stewardship.
  Represent Perrigo in external forums and trade associations to advocate CMC policy and best practices.
• Address CMC risks from ingredient challenges and lead mitigation planning with Regulatory Product Stewardship.

Lifecycle Management (LCM) Leadership

• Establish and lead the global LCM model, structure, and ways of working.
• Develop and execute regulatory LCM strategies across all product categories (Drug, Device, Cosmetic, Food, Supplement, Monograph, Herbal, Biocide).
• Ensure seamless handover of regulatory activities post-launch with the Regulatory Category team.
• Lead change management for marketed products, including impact assessments, submissions, and implementation tracking.
• Align LCM strategies with commercial, R&D, and BD goals for growth, expansion, and cost optimization.
• Oversee regulatory execution of post-approval changes (variations, renewals, extensions, label updates).
• Collaborate with Quality, Supply Chain, and R&D to ensure robust change control and regulatory compliance.
• Monitor evolving global regulations and proactively update dossiers and documentation.
• Drive process improvements to accelerate change implementation and enhance regulatory efficiency.
• Provide regulatory leadership for product discontinuations, divestitures, and portfolio optimization.
• Ensure alignment across functions for commercial strategy, manufacturing changes, and supply continuity.
• Maintain oversight of regulatory tracking systems and metrics for visibility and accountability.
• Represent Perrigo in external LCM forums and industry groups to shape best practices and modernization.

Regulatory Operations

• Lead global regulatory operations: submissions, publishing, document management, and systems.
• Develop integrated data management strategy and oversee regulatory technology platforms.
• Ensure data integrity, compliance, and drive digital transformation to enhance efficiency.
• Advance Perrigo’s regulatory digital platforms, data governance, and automation.
• Ensure global compliance with submission standards and evolving requirements.

Organizational Leadership

• Build and lead a high-performing global team with expertise in CMC, Regulatory Operations, and LCM.
• Foster a culture of excellence, agility, innovation, and continuous learning.
• Develop talent pipelines and succession plans for long-term capability.

Experience Required

• Advanced degree in Life Sciences (PhD, PharmD, MSc preferred).
• 15+ years of progressive experience in regulatory affairs, with leadership roles in CMC, Regulatory Operations, and Lifecycle Management.
• Proven track record of successful global submissions and approvals across diverse product categories.
• Strong strategic, financial, and operational acumen.
• Exceptional leadership, collaboration, and stakeholder engagement skills.
• Experience with global regulatory systems and digital platforms.
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Key Competencies:

• Strategic Foresight & Policy Influence
• Scientific & Regulatory Acumen
• Executive Communication & Stakeholder Management
• Innovation Enablement & Digital Fluency
• Global Leadership & Talent Development
• Operational Excellence & Change Management