Associate Director - CMC Regulatory Affairs
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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, navigate regulatory landscapes, deliver timely submissions, and proactively identify risks and mitigation plans, enabling first‑to‑market approvals that enhance Perrigo’s reputation as a global leader in CMC.
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 defense, 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.
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.
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. We promote flexibility with the ability to work two days a week from home in many roles.
Equal Opportunity Employment
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.
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