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Regulatory Affairs Specialist ( Publishing ) Makrocare

2.0 - 4.0 years

3 - 6 Lacs

hyderabad, madhapur

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Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Docu...

Posted 3 hours ago

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