Regulatory Affairs Project Manager

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, Compeed, Solpadeine, NiQuitin, ACO, 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

We are currently seeking a Regulatory Affairs Project Manager to join our highly successful Central Regulatory Affairs medicines team.

This role is responsible for managing new Marketing Authorisation and life cycle maintenance projects for medicinal product portfolios across the EU, ensuring compliance with legislative frameworks and internal policies. Our medicines team operates from multiple locations in the EU, with main hubs in London, Paris, Ghent, and Rotterdam.

As a Regulatory Affairs Project Manager, you will lead regulatory projects from strategy to approvals, working with central and local Regulatory teams to ensure our products comply with relevant legislation, including the EU Medicines Directive and Variation Regulation as well as other national legislation.

You will maintain regulatory compliance, stay updated on regulatory requirements, and implement necessary changes.

Additionally, you will support various regulatory and cross functional areas, helping to create and maintain robust ways of working and collaboration.
A strong background in EU regulatory affairs for medicinal products, with excellent communication skills, attention to detail and demonstrated ability to manage multiple ongoing projects are essential.

Scope of the Role

• Lead regulatory activities for assigned projects and brands; providing updates to stakeholders and reporting against project plans.
• Support brand management, including product name strategy, core product information text, review of claims, global advertising material and pack design.
• Develop regulatory strategies for product lifecycle maintenance and new MAA projects, identifying risks and opportunities.
• Manage, execute and coordinate product lifecycle maintenance projects (including variations, renewals and safety updates) and new MAA applications.
• Develop, roll out and maintain relevant internal procedures and best practices.
• Support the regulatory intelligence best practice and implementation of changes to legislation.
• Support CSCI RA engagement and enablement projects.
• Maintain the integrity of regulatory data in the relevant databases.
• Carry out any other regulatory tasks as required.

Experience Required

• Bachelor or Master’s degree in International Law, European Policies, Medical/Life Sciences or other relevant fields.
• 5 years of experience in a relevant regulatory environment.
• Experience in drug development and manufacturing supply processes.
• Knowledge of specific regulatory requirements in Europe.
• Self-motivated, flexible and open to changing requirements.
• Highly driven with enthusiasm to meet requirements and cope under demanding pressure.
• Excellent spoken and written communication skills; able to represent Perrigo during interactions and negotiations with external agencies.
• High accuracy and attention to detail.
• Project management skills and the ability to work autonomously with guidance when required.
• Ability to make decisions, problem solve, prioritise and multi-task.
• Ability to influence, negotiate and manage stakeholders.
• Focus on continuous improvement.
• Provide coaching, mentoring and knowledge within the Regulatory department.

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 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 here

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an 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. #weareperrigo