Associate Director - CMC Regulatory Affairs

Associate Director - CMC Regulatory Affairs

Perrigo

Multiple Locations

Description Overview

As Associate Director, you will lead 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.

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

You will inspire and empower a high-performing regulatory team, instilling a culture of agility, compliance, and continuous improvement.

Scope of the Role

• Lead global CMC regulatory strategy and execution for innovation projects, post-approval changes, lifecycle management, and compliance across all product categories;
• Oversee the preparation, review, and submission of high-quality CMC documentation (e.g., Module 3, Quality Overall Summary) for global health authority submissions, including new MAAs/NDAs/ANDAs, variations, renewals, and compliance updates;
• Develop and implement response strategies for regulatory queries and deficiency letters related to CMC matters. Engage in technical discussions with Competent Authorities in partnership with Country Regulatory teams;
• Collaborate with cross-functional teams to ensure regulatory CMC alignment with commercial strategy, manufacturing changes, and global supply continuity;
• Manage CMC strategy and documentation for complex CMC projects, such as tech transfers, major reformulations and geo-expansion;
• Manage CMC risks associated with ingredient challenges and develop action plans to support defence, in partnership with Regulatory Product Stewardship team;
• Monitor global CMC regulatory trends and new regulations and guidance. Provide product impact assessments and strategic guidance to ensure continued compliance and readiness for evolving requirements, in partnership with Regulatory Product Stewardship team;
• Represent Perrigo in external regulatory forums and trade associations to advocate for CMC-related policy positions and regulatory best practices;
• Build and lead a high-performing, globally distributed team with deep expertise in CMC;
• Foster a culture of excellence, agility, innovation, and continuous learning;
• Develop talent pipelines and succession plans to ensure long-term organizational capability.

Experience Required

• Advanced degree in Life Sciences (PhD, PharmD, MSc preferred);
• 15+ years of progressive experience including management roles in CMC;
• 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.