Senior Regulatory Affairs Professional

2 weeks ago


Cambridge, Cambridgeshire, United Kingdom VCLS Full time

Regulatory Affairs Role


We are seeking a highly skilled Regulatory Affairs professional to support our Clinical Trial Submissions (CTS) group.


This role is ideal for someone with experience in regulatory affairs and a strong background in Clinical Trial Submissions.


Key Responsibilities



  • Identify and coordinate international, national, and local regulatory requirements for clinical trial submissions across various countries.
  • Draft, review, and ensure the quality of all documents related to Clinical Trial Application (CTA) dossiers in accordance with local and regional regulations.
  • Provide regulatory review of core study documents (e.g., protocols, Investigator's Brochure, informed consent forms, and labels) to ensure compliance with regulatory standards.
  • Perform quality control (QC) on CTA packages before submission to regulatory authorities.
  • Draft and QC responses to client inquiries and provide timely, accurate regulatory guidance.
  • Liaise with regulatory authorities and service providers to support the submission process.
  • Lead or participate in regular video/teleconferences with clients to provide status updates on the regulatory progress of their studies.

Requirements



  • 4+ years of experience in Regulatory Affairs, with a specific focus on Clinical Trial Submissions (CTS).
  • Deep understanding of regional and local regulatory requirements for clinical trials.
  • Strong organizational and communication skills.
  • Experience working with regulatory authorities and managing client relationships in a professional setting.
  • A proactive approach to problem-solving, with strong attention to detail.

About VCLS


VCLS is a innovative and growing company that values regulatory science and compliance.


We are committed to delivering high-quality clinical trial submissions and regulatory services to our clients.



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