Export Regulatory Affairs Specialist (CTD)

• Collect and coordinate information and prepare regulatory CTD documentation for submission to regulatory agencies, authorities or to commercial partners.
• Expertise proficiency with software tools and matrices for CTD submission.
• Select and prepare CTD for products according to management instructions.
• Coordinate with the R&D, Q.C, Q.A, Production, Supply chain and Marketing team members regarding the different registration issues and documents required for CTD preparation.
• Ensure confidentiality in respect of CTD registration files contents.
• Review carefully compiled CTD files to ensure that content, quality; accuracy and format of submission comply with applicable regulations of different markets.
• Perform other related duties as assigned.

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