Regulatory Affairs EXECUTIVE @ MUMBAI-R

Executive - Regulatory Affairs
Samridhi Placements - Navi Mumbai, Maharashtra

Preparation of datasets for Pre-IND meeting requests, coordination with internal stakeholders, compilations and submission of Bio-INDs, IND package s to USFDA Dossier compilation in CTD format for NDAs and or 505 (B)(2 ) and ANDA submission to USFDA, Dossiers to ICH region and other regions such as Canada, Australia, Newzealand Document compliance of different dossier documents for adequacy and accuracy.

• It includes mainly Exhibit batch document, Vendor document and RD documents and other related documents.
• Coordination with all involved parties in a product life cycle in product development, dossier compilation, query phase and post approval changes.
• Management of dossier data and updating scientific information within organization in the field of regulatory.
• Impact analysis on submitted dossiers during assessment phase due to change in regulations or requirements.
• Liasoning with project management team for maintaining timelines for dossier submission

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