Hetero is hiring Regulatory Affairs- API ( Domestic Market)
Position: Regulatory Affairs- API ( Domestic Market)
Location: Raidurg,Hyderabad
Experience: 2-6 Years
Department: Product Managerment
Job Responsibilities:
1.Responsible for complete API License applications in Bulk (API) National Regulatory submissions for API projects .
2.Review of CMC Data required for regulatory agencies (Analytical reports, process validation reports, Pharmaceutical
development reports, Protocols & Stability data) Export applications (Documents Support for Country specific)
3.API Documents support to formulations applications, IPC Analysis applications for the grant of permission to
Manufacturing and marketing.
4.Maintain the excel sheets . (Product License copies List)
5.Travel to internal units for API’s License work and CDSCO Inspections & audits.
6.All the loan license and their license applications shall be handled
7.Responding to related queries regulatory guidance.
8.Good knowledge Pharma Guidelines .
9.Resolving Regulatory queries raised after submission of application to DCA and CDSCO.
10.Follow-up the status after the application Submissions.
11.Filing – Maintain file for every application and Documents.
12.Supporting liasoning department for getting different pharma licensing certificates.
