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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | R&D / Product Design |
| EmploymentType | Full-time |
Position : Regulatory Affairs - API ( US ,Europe and CEP Markets)To write, check/review of documents as per regulatory requirements To publish with software submission documentation as per regulatory requirements To response to regulatory deficiencies letters according to EU and USA regulatory requirements. To support local in-licensing To collaborate with other departments/partners To maintain lists/documents/records To achieve his/her responsibilities within the agreed timescales To actively participate in the development of regulatory skills within the regulatory team by continuous up-datingMust have faced and having very good exposure for maximum 50-60 regulatory audits for US ,Europe and CEP markets .Should have handled a team of max 20-30 employees.
Keyskills :
new drug applicationrisk analysisin-licensingelectronic common technical documentdocumentationcommon technical documentregulatory intelligenceregulatory requirementsneesabbreviated new drug applicationregulatorycmc regulatory affairsregulat