Hetero is a globally renowned vertically integrated pharmaceutical player engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 27+ years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world.
Experience: 2 to 8 years
Industry: Pharma Industry(Mandatory)
UG: B.Pharma in Pharmacy
PG: MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization
- Well versed with the concepts of pharmaceutical analysis, regulatory trials, laboratory testing of drugs, good manufacturing practices etc.
- Regulatory Documentation, Dossier preparation in e-CTD/ CTD/ ZACTD format, handling documentation related to MOH Drug Registration, Regulatory strategy, responding to queries of health authorities, Pharmaceutical product registration
- Strong background in providing responses to regulatory agencies regarding product information or issues
- Keen communicator with honed problem solving and analytical abilities
- Coordinating with Quality Assurance, Quality Control, Formulation, Research & Development departments as well as reviewing the technical documents as per the guideline or checklist for preparation of dossier in CTD format
- Carrying out periodic self-inspection for proper dossier preparation as per the updated registration guideline to improve efficiency / compliance
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