Submission Coordinator

4 days ago


Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full time

**Job Description:**
We are looking for a highly skilled Submission Coordinator to join our team. As a key member of our submission team, you will be responsible for ensuring that our submissions are accurate, consistent, and compliant with regulatory submission requirements. Your expertise will play a critical role in delivering high-quality submissions that meet the strict requirements of regulatory authorities.

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**Responsibilities:**
Collect, organize, and track documentation required for Marketing Authorisation applications; Check documents for accuracy, consistency, deficiencies, and compliance with regulatory submission requirements; Compile module 1-5 CTD registration package for new Marketing Authorisation submissions; Submit necessary applications through electronic gateway; Respond to regulatory information requests.

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**Requirements:**
To succeed in this role, you should have knowledge of CTD compilation and eCTD structure and requirements. Proficiency in publishing and compilation of eCTD submissions, as well as eCTD validation and viewing tools, is essential. You must also be able to work independently with minimal supervision and collaborate effectively with cross-functional teams.

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**Estimated Salary:** £65,000 - £85,000 per annum.

**Our Company Culture:**
We pride ourselves on fostering a positive and inclusive work environment where everyone feels valued and supported. We believe in empowering our employees to take ownership of their work and contribute to the success of our team.



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