Regulatory Affairs Professional
3 hours ago
We are seeking a highly skilled Regulatory Affairs professional to maintain product licences held by our client, ensuring new licence applications are submitted appropriately and that licences are kept up to date with the relevant Regulatory Authorities.
This role is home-based in North West England, working as part of a team supporting our client's commitment to ethical and social responsibility in research and development.
Key Responsibilities:
- 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.
An attractive salary package, estimated at £60,000 - £80,000 per annum, will be offered to the successful candidate, reflecting the importance of this role in supporting our client's mission and values.
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