Senior Regulatory Affairs Associate - 6 Month Fixed Term Contract

Senior Regulatory Affairs Associate - 6 Month Fixed Term Contract

Location: London, GB, SW11 7BW

Description Overview

As a member of the Europe North Cluster Regulatory Affairs Team, the Senior Regulatory Affairs Associate will focus on post marketing regulatory activities for medicinal products within the UK and Ireland.

This role is a 6 month Fixed Term Contract.

Scope of the Role

• Work on Regulatory Affairs projects & product changes to meet business needs.
• Comply with the existing legislation and regulations for medicines.
• Ensure product registrations are correct and compliant with the relevant legislation.
• Establish, review, approve and update regulatory documentation.
• Prepare & submit variations 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 stakeholders.
• Communicate with local regulatory authorities regarding license applications and variations.
• 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.
• Carry out other related regulatory affairs duties as required.

Experience Required

• A scientific degree in a pharmaceutical, chemical or biological discipline.
• 3 years Regulatory Affairs, ideally within UK or EU OTC including Post Marketing Licence Maintenance activities.

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. However, we also appreciate the opportunity to work remotely, which can energise you, so we promote flexibility with the ability to work two days a week from home in many roles.

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.