At Perrigo, we are driven by our mission to Makes 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.
Dedicated to providing The Best Self:
Care for Everyone, we are the people behind the brands you trust.
We are Opill(R), Compeed(R), Solpadeine(R), NiQuitin(R), ACO(R), and many more.
We Are Perrigo.
We are committed to enhancing the wellbeing of our colleagues and consumers alike.
We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to a blended:
branded business to win in self:
care.
Description Overview
Within our global and international Scientific Affairs team, were looking for our newCMC RegulatoryAffairsProjectManager to join our team either based in our office in Chatillon (France) or London (UK).
As a CMC RegulatoryAffairsProjectManager, 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.
To learn more about our products and solutions:
Consumer Self:
Care Products and Solutions
Scope of the Role
In this role, you will lead CMC RegulatoryAffairsProjects, providing updates to the business and reporting against project plans.
You will develop regulatory strategies for CMC aspects of new MAAs, new product development projects, and life cycle maintenance activities.
Completing due diligence on time for assigned product dossiers, identifying risks and opportunities, will be a key part of your responsibilities.
Main missions
:
Support the technical team with scientific expertise to define development or validation plans for assigned projects.
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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.
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Manage,write and maintainthe technical/quality part of CMC dossiers, such as complex MA variations like site transfer and reformulation projects.
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Ensure continuity of supply and timely submission of new products and resolve regulatory issues with Health Authorities and address artwork:
related issues.
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Provide CMC support for MDR:
related changes to the medicinal CTD and offering CMC expertise and RA activity in support of emerging ingredient issues in compliance with related guidance.
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Play an active role in quality management by managing requests for changes, preparing annual product quality reviews, and addressing product quality control matters.
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Developand maintainrelevant internal procedures and best practices.
Maintainthe integrity of regulatory data in relevant databases by interpreting and implementing legislation, following changes in national regulations, and proactively manage the impact of these changes.
Background and Profile
We are looking for candidates with a University Degree or equivalent scientific qualification and a minimum of 7 years of relevant work experience, preferably in CMC RegulatoryAffairs or R and D.
Practical experience in at least one specific product type and a background knowledge of healthcare products, such as medicines, medical devices, and cosmetics, is required.
You also have an experience in CMC and pharmaceutical life cycle management and in due diligence of CMC dossiers (3.2.P and 3.2.S).
An experience in Nitrosamines project management would be a plus.
The ideal candidate will be self:
motivated, flexible, and open to changing requirements.
