Regulatory Affairs Deputy Manager

Select Pharma

Posted 14 days ago, valid for a month

£50,000 per annum

Full Time

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Sonic Summary

The job involves collecting, organizing, and tracking documentation for Marketing Authorisation applications in eCTD format.
Candidates should have experience in CTD compilation and a strong understanding of submission requirements for EU submission types.
The role requires proficiency in publishing and validating eCTD submissions and the ability to work independently or as part of a team.
A minimum of 3 years of relevant experience is required, with a salary range of $70,000 to $90,000 per year.
The position also includes assisting in regulatory compliance and communication with product development teams.

Responsibilities:

Responsible for collecting, organising, and tracking of documentation required for Marketing Authorisation application and response to questions in eCTD format.
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
Assist Companys business in delivering quality regulatory submissions to agreed project targets.
Participate to the review of process/product changes and batch recall to determine the need for any regulatory activities and to ensure compliance to regulatory requirements;
Assist Department Head in developing procedures to ensure regulatory compliance.
Familiar with work instructions practices, and procedures of the Company.
Communicate with product development teams and organise meetings for tracking project status and timelines.
Any other reasonable duties as directed by your line manager or Director.

Required Skills:

Knowledgeable in CTD compilation.
Knowledgeable in CTD/eCTD structure and requirements and firm understanding of submission requirements for EU submission types
Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools
Ability to work independently with minimal supervision as well as work in a team environment with changing timelines and priorities.

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