Regulatory Affairs Specialist

2 weeks ago


Windsor, Windsor and Maidenhead, United Kingdom Chase Full time

The Regulatory Affairs Executive plays a crucial role in ensuring the compliance of our company's products with regulatory requirements. This position requires excellent communication and organisational skills to manage multiple tasks and deadlines. The successful candidate will have experience working in a pharmaceutical regulatory environment, with a strong understanding of legislative procedures and processes.

Key responsibilities include preparing and submitting applications for new marketing authorisations, renewals, variations, and changes of ownership to regulatory authorities. Additionally, the candidate will prepare and publish regulatory submissions in eCTD format, update the Regulatory Information Management System (RIMS), and respond to questions from regulatory authorities.

The ideal candidate will have strong IT skills, including MS Excel, Word, and PowerPoint, as well as high-level attention to detail and accuracy. A good planning and organisation skills are also essential for this role. We offer an excellent salary and benefits package.



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