Regulatory Affairs Professional

2 days ago


Cambridge, Cambridgeshire, United Kingdom VCLS Full time
Role Overview

We are seeking a highly experienced Regulatory Affairs professional to join our Clinical Trial Submissions (CTS) group. As a key member of our team, you will play a pivotal role in driving forward regulatory processes, ensuring compliance, and contributing to innovative clinical trials.

This is an ideal opportunity for someone with 4+ years of experience in Regulatory Affairs and a strong background in Clinical Trial Submissions. You will have the chance to work under a generous leader who is known for her authentic communication style and her genuine commitment to the growth and development of her team members.

You will be responsible for identifying and coordinating international, national, and local regulatory requirements for clinical trial submissions across various countries. Additionally, you will draft, review, and ensure the quality of all documents related to Clinical Trial Application (CTA) dossiers in accordance with local and regional regulations.

Your other responsibilities will include providing regulatory review of core study documents, performing quality control (QC) on CTA packages, maintaining and updating study status tracking tools, drafting and QC responses to client inquiries, creating and maintaining internal knowledge management tools, collaborating with subject matter experts, and liaising with regulatory authorities and service providers.



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