Senior 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®, 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 win in self-care.

Description Overview

In this role you will work on Regulatory Affairs projects and product changes as required to meet business needs.

You will also manage compliance with the existing legislation and regulations.

Scope of the Role

• Work as part of a multi-functional team by providing regulatory input to new product development and associated supporting documentation, complete due diligence on time for any assigned product dossiers.

• Work as part of the team to ensure product registrations are correct and compliant with the relevant legislation.

• Establish, review, approve and update regulatory documentation

• Prepare and publish packages and submit MAA’s and variations to meet the business needs via the electronic platforms

• Maintain accurate and complete records by updating the relevant trackers, product folders and regulatory databases

• Approve Artwork and Texts from a regulatory perspective

• Participate in project meetings with both internal and external contacts

• Communicate with local regulatory authorities regarding license applications and variations

• Interpret and implement legislation, follow changes in national regulations and legislations and proactively manage impact of these changes

• Maintain oversight of the assigned projects, keep informed of any issues affecting product compliance or supply to market and take prompt action when urgent issues arise. Follow up closely with stakeholders to ensure resolution and timely closure of such issues

• Support marketing and sales with claims creation and copy review, as per internal guidelines

• Provide input for analysis of data and/or management review, if required

• Carry out other related regulatory affairs duties as required

Experience Required

• Minimum of 3 years' experience in Regulatory Affairs, with a strong focus on UK and/or EU Biocides and experience of working with UK HSE.

• Experience of working with OTC medicines desirable.

• Proven expertise in post-marketing license maintenance, including variation submissions, renewals, and regulatory compliance.

• Experience with Marketing Authorisation Applications (MAAs) is highly 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.

Find out more about 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 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