Regulatory Affairs Executive
Ciron Drugs & Pharmaceuticals Pvt. Ltd. At:- Mumbai, Maharashtra, India
About the jobResponsibilities
• Preparation and submission of registration dossier in eCTD format for US & EU market.
• Having knowledge for documents (PDF) processing work.
• Having knowledge for PASS, CBE-0, CBE-30 (for US) & post approval application for EU.
• Coordinate with Plant, R&D & CQA & ADL department for technical documents and to review the documents for accuracy as per ICH or Country specific requirement.
• Ensuring that quality standards are met and submissions meet within stipulated timelines.
• Responsible for Compilation & Review of Quality documents like Module 2 & 3.
• Liaise with marketing for the finalizing the product pipelines and providing required dossiers
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