Hetero Pharma Hiring For Regulatory Affairs Specialist -API
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| Hetero Pharma Hiring For Regulatory Affairs Specialist -API |
Hetero Pharma Hiring For Regulatory Affairs Specialist -API
Regulaotry Affairs Specialist-API
Experience : 2 to 8 Yrs
Industry : Pharma
Location : HRF Balangar,Hyderabad
ROLES & RESPONSIBILITIES :
•Coordinating with cross functional teams for collection and interpretation of data required for compilation of DMF/ASMF /CEP CMC sections.
•Compilation of administrative and CMC sections (Module-1, Module-2 and Module-3) of Drug Master File/ASMF/CEP in compliance with regulatory guidelines.
•Compilation of DMF/ASMF/CEP in eCTD format by using Pharma ready software.
•Submission of initial/amendments/responses to deficiencies/annual reports of DMF, ASMF to USFDA and Health Canada through Electronic submission gateway.
•Submission of initial/amendments/deficiencies of ASMF to European countries, CEP (Certificate of suitability) to EDQM through CESP portal.
•Preparation of establishment registrations and labels using SPL in Pharma ready software.
•Preparation of Generic Drug User Fee Cover Sheet for facilities and Type-II DMF.
•Maintaining regulatory submissions database and archive correspondence documents.
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