Deputy Regulatory Manager

Responsibilities:

1. Responsible for collecting, organising, and tracking of documentation required for Marketing Authorisation application and response to questions in eCTD format.
2. Check documents for accuracy, consistency, deficiencies, and compliance with regulatory submission requirements.
3. Compile module 1-5 CTD registration package for new Marketing Authorisation submissions.
4. Submit necessary applications through electronic gateway.
5. Respond to regulatory information requests.
6. Assist Company’s business in delivering quality regulatory submissions to agreed project targets.
7. Participate in the review of process/product changes and batch recall to determine the need for any regulatory activities and to ensure compliance with regulatory requirements.
8. Assist Department Head in developing procedures to ensure regulatory compliance.
9. Familiar with work instructions, practices, and procedures of the Company.
10. Communicate with product development teams and organise meetings for tracking project status and timelines.
11. Any other reasonable duties as directed by your line manager or Director.

Required Skills:

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

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