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- 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.
