Compliance and Licensing Executive
4 hours ago
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.
- 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.
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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