Deputy Regulatory Affairs Manager
Regulatory Affairs ManagerResponsibilities:
* 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.
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