Regulatory Affairs Associate

Description Overview

We have an exciting opportunity in our Central Regulatory Affairs team for a Regulatory Affairs Associate to work with our branded medicines portfolio.

We offer a hybrid working pattern based in one of our main offices in London, Ghent, Paris or Rotterdam.

The main responsibilities of the role will be to work on a diverse range of post-authorisation Regulatory projects across European territories to meet business needs and ensure Regulatory compliance of the Company’s products with all relevant legislation. This role provides an excellent opportunity to further develop skills for executing and managing the regulatory activities needed to maintain Marketing Authorisations across numerous territories. It also offers the opportunity to support pre-authorisation Regulatory activities such as a new Marketing Authorisation Applications, according to business needs.

Scope of the Role

• Be a trusted Central RA voice concerning maintenance of our medicinal product portfolio, working in close partnership with a cross functional team and supporting Local RA teams to ensure successful and timely delivery of regulatory activities
• Deliver the regulatory actions needed to get products to market and keep them there with optimized positioning as per the business strategy
• Prepare and submit product license variations, renewals, PSUR submissions and other post-authorisation applications to meet the business needs in accordance with current legislation, via the electronic platforms
• Maintain oversight of the assigned projects, escalate any identified risks to compliance or supply and take prompt action when urgent issues arise. Follow up closely with stakeholders to ensure resolution of issues and timely project completion
• Produce clear written communications, tailored to the target audience, to convey understandable and appropriate messages to both internal and external stakeholders, as required
• Support all Central Regulatory lifecycle maintenance activities
• Assess the Regulatory impact of Administrative, Quality and Safety-related change controls and complete any related actions in accordance with procedures in place
• Maintain accurate and complete records by updating the relevant trackers, product folders and regulatory databases used by the Central RA team
• Support the development and training of Regulatory best practice and procedural documents
• Report on task and project progress, when required, to Line Manager, other stakeholders and via relevant regulatory tracking tools in accordance with best practice and procedures in place
• Carry out other related regulatory affairs duties as required

Experience Required

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. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV #weareperrigo