CMC Regulatory Affairs Project Manager

At Perrigo, we are driven by our mission to make lives better through trusted health and wellness solutions, accessible to all. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over-the-counter and infant formula. We are committed to enhancing the wellbeing of our colleagues and consumers alike, fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Description Overview

Within our global and international Scientific Affairs team, we are looking for a CMC Regulatory Affairs Project Manager to join our team in our office in London (UK). As a CMC Regulatory Affairs Project Manager, you will lead complex CMC projects for a large range of our healthcare portfolio, such as territory extensions, new registrations, and new formulas. You will further develop your skills in defining CMC strategies and executing complex site transfer and CMC projects. Additionally, you will contribute to functional change projects, executing improvements within the team.

Scope of the Role

In this role, you will:

• Lead CMC Regulatory Affairs Projects, providing updates to the business and reporting against project plans.
• Develop regulatory strategies for CMC aspects of new MAAs, new product development projects, and life cycle maintenance activities.
• Complete due diligence on time for assigned product dossiers, identifying risks and opportunities.
• Support the technical team with scientific expertise to define development or validation plans for assigned projects.
• Review technical documentation generated by the site during development or validation of site transfer projects and support Change Controls by providing RA assessment, strategy, and appropriate actions.
• Manage, write and maintain the technical/quality part of CMC dossiers, such as complex MA variations like site transfer and reformulation projects.
• Ensure continuity of supply and timely submission of new products and resolve regulatory issues with Health Authorities and address artwork-related issues.
• Provide CMC support for MDR-related changes to the medicinal CTD and offer CMC expertise and RA activity in support of emerging ingredient issues in compliance with related guidance.
• Play an active role in quality management by managing requests for changes, preparing annual product quality reviews, and addressing product quality control matters.
• Develop and maintain relevant internal procedures and best practices.
• Maintain the integrity of regulatory data in relevant databases by interpreting and implementing legislation, following changes in national regulations, and proactively managing the impact of these changes.

Experience Required

We are looking for candidates with:

• A University Degree or equivalent scientific qualification.
• A minimum of 7 years of relevant work experience, preferably in CMC Regulatory Affairs or R&D.
• Practical experience in at least one specific product type and a background knowledge of healthcare products, such as medicines, medical devices, and cosmetics.
• Experience in CMC and pharmaceutical life cycle management and in due diligence of CMC dossiers (3.2.P and 3.2.S).
• Experience in Nitrosamines project management would be a plus.
• The ability to work effectively both autonomously and in teams, along with good interaction skills with internal and external stakeholders.
• The ability to handle multiple complex projects in parallel with high accuracy and attention to detail.
• Fluency in English is mandatory; French is desirable.

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 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".

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.