Regulatory Affairs Associate

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

We are currently seeking a Regulatory Affairs Associate to join our highly successful Central Regulatory Affairs medicines team. This role is responsible for supporting life cycle maintenance activities in 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 Associate, you will execute projects and ensure our products comply with relevant legislation, including the Medicines Directive 2001/83/EC and Variations Regulations EC/1234/2008. You will maintain regulatory compliance, stay updated on regulatory requirements, and implement necessary changes. Additionally, you will support various regulatory and quality areas, including submissions and documentation preparation. A strong background in regulatory affairs and attention to detail is essential.

Scope of the Role

1. Prepare and submit product license variations and other post-authorisation applications in accordance with current legislation.
2. Communicate with international regulatory authorities regarding applications and compliance issues.
3. Support all central Regulatory lifecycle maintenance activities.
4. As part of the team, support the process of obtaining new Marketing Authorisations.
5. Support the regulatory intelligence best practice and implementation of changes to legislation.
6. Assess the impact of Administrative, Quality and Safety-related change controls and complete any related actions in accordance with procedures in place.
7. Support the maintenance of current Regulatory Systems used by the central team.
8. Support the development and training of best practice and procedural documents.
9. Manage and communicate task progress to Line Manager and report via relevant regulatory tracking tools in accordance with best practice and procedures in place.
10. Carry out other related regulatory affairs duties as required.

Experience Required

1. Bachelor or Master’s degree in Medical/Life Sciences, International Law, European Policies or other relevant fields.
2. Minimum one year experience in a Regulatory environment.
3. Good system handling skills (Samarind, Trackwise, Microsoft Office).
4. High attention to detail.
5. Ability to set priorities and handle multiple tasks simultaneously.
6. Highly driven with enthusiasm to meet requirements and cope under demanding pressure.
7. Ability to work autonomously and in team - very good organization of own work.
8. Being keen on innovation and creative thinking.

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".

Applicants please note: 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