Regulatory Affairs - Senior Associate

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. Dedicated to providing the best self-care for everyone, we are the people behind the brands you trust. 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 hiring a talented Senior Regulatory Affairs Associate who will be responsible for the hands-on regulatory activities associated with maintaining the portfolio of branded products within the Perrigo UKIE business. Our office is in central London.

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.
• 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 the impact of these changes.
• Support marketing and sales with claims creation and copy review, as per internal guidelines.
• Carry out other related regulatory affairs duties as required.

Experience Required

Our ideal candidate should have a minimum of 3 years' experience in Regulatory Affairs, working with OTC medicines, including Post Marketing License Maintenance activities, renewals and safety updates. You should be familiar with working in CC-systems (e.g. TrackWise) and eCTD publishing tools. The person we are looking for should be:

• Self-motivated, flexible and open to changing requirements.
• Highly driven with enthusiasm to meet requirements and cope under demanding pressure.
• The ability to work autonomously and in a team.
• The ability to support several concurrent activities.
• Excellent communication in English.
• Excellent problem-solving skills.
• Being thorough, focused and detail oriented.

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".

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.