Regulatory Manager

We Are Hiring in Regulatory Affairs!!

Location: Dholka, Gujarat.

Key Deliverables of the Role:

• Compilation, review and submission of registration dossiers in the regions of US.
• Handling of regulatory queries/deficiencies.
• Post approval activities: Review of Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS) submission.
• eCTD software handling for ANDA/IND submission, query response and post approval submission.
• Review and approval of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols/ process validation protocols/Process validation reports Batch manufacturing records, Batch Packaging records, Formula clearance etc.
• Review of Analytical method validation / verification / transfer reports.
• Review of DMF and its notifications.
• Review and approval of Change Controls & Deviations.
• Creation and Maintenance of Regulatory Database for all the submissions.
• Tracking of Regulatory Guidance Documents at the respective websites.
• Imparting training across the team on new guidance documents.