Deputy Regulatory Affairs Manager

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.