Associate Director - CMC Regulatory Affairs

Perrigo; Châtillon; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

A leading healthcare company is seeking an Associate Director to lead the development and execution of innovative Chemistry, Manufacturing & Control (CMC) strategies. In this role, you will oversee the preparation of high-quality documentation for regulatory submissions, ensuring compliance across various product categories. The ideal candidate will have a strong background in Life Sciences, with over 15 years of progressive experience, including leadership roles. This role promotes a hybrid working model, offering flexibility alongside competitive compensation and career development opportunities.

Prestations

Competitive compensation

Career development opportunities

Hybrid working approach

Qualifications

• Advanced degree in Life Sciences (PhD, PharmD, MSc preferred).
• 15+ years of progressive experience in CMC, including management roles.
• Proven track record of successful global submissions and approvals.

Responsabilités

• Lead global CMC regulatory strategy and execution for innovation projects.
• Oversee the preparation and review of high-quality CMC documentation.
• Develop response strategies for regulatory queries related to CMC.

Connaissances

Leadership

Strategic thinking

Regulatory compliance knowledge

Cross-functional collaboration

Problem-solving

Formation

PhD, PharmD, or MSc in Life Sciences

Description du poste

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 assistants.

< Kashmir Elk

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 أجto‑market approvals that enhance Perrigo’s reputation as a global leader in CMC.

آپ 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 Sprecher comprehensive action plans to support defense, inчноpe…
• 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+ değerli progressive experience including management rolesintas in CMC.
• Proven track record of successful global submissionsે 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-used tailored to add-supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, professionally and personally. Find out more 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." Find out more.

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE buttonриди only saves your profile information but not submit ഇന്നറ application for this open position.) Thank you. 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.

Associate Regulatory • Chatillon Cedex, FR