Compliance and Licensing Executive

4 hours ago


Eastern England, United Kingdom CHASE Full time
Role Description: We are seeking a Compliance and Licensing Executive to join our team at CHASE, a leading company in the pharmaceutical industry. In this role, you will be responsible for maintaining product licences held by our client, ensuring compliance with Regulatory Authorities. This position is home-based in North West England and requires a strong understanding of Regulatory Affairs legislative procedures and processes.

Main Tasks:
  • Submit applications for Marketing Authorisations, renewals, variations, and changes of ownership to the Regulatory Authorities.
  • Publish regulatory submissions in eCTD format and update the Regulatory Information Management System (RIMS).
  • Prepare responses to questions from the Regulatory Authorities.
  • Follow up on submissions and regulatory issues with the authorities.
  • Request, review, and submit Periodic Safety Update Reports (PSURs) as required.
  • Negotiate and liaise with 3rd party companies and other departments concerning submission applications.
  • Write, review, and advise on SmPCs and packaging.
Profile:
  • Experience in pharmaceutical regulatory/licensing environments.
  • Knowledge of Regulatory Affairs legislative procedures and processes.
  • Strong communication and interpersonal skills.
  • Able to work well in a team environment.
  • Good planning and organisational skills.
  • High attention to detail and accuracy.
  • Proficiency in MS Excel, Word, and PowerPoint.
  • High standard of literacy and written communication.
Remuneration:

The remuneration package for this role includes a competitive salary range of £70,000 - £90,000 per annum, along with a comprehensive benefits programme.



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