Product Licence Specialist

2 days ago


Eastern England, United Kingdom CHASE Full time
Job Overview: As a Product Licence Specialist, you will play a critical role in 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 Responsibilities:
  1. Submit applications for Marketing Authorisations, renewals, variations, and changes of ownership to the Regulatory Authorities.
  2. Publish regulatory submissions in eCTD format and update the Regulatory Information Management System (RIMS).
  3. Prepare responses to questions from the Regulatory Authorities.
  4. Follow up on submissions and regulatory issues with the authorities.
  5. Request, review, and submit Periodic Safety Update Reports (PSURs) as required.
  6. Negotiate and liaise with 3rd party companies and other departments concerning submission applications.
  7. Write, review, and advise on SmPCs and packaging.
Requirements:
  • 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.
Compensation:

The compensation package for this position includes an attractive salary range of £65,000 - £85,000 per annum, along with a comprehensive benefits programme.



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