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Regulatory Affairs Executive (API)
Hetero Drugs
posted 9hr ago
Job Description
- Preparation and Compilation of DMFs in-line with regulations of Regulatory and Semi-Regulatory countries.
- Supporting to the concerned Marketing department/teams in terms of providing appropriate documents.
- Coordinating effectively with all cross functional teams (QC, QA, R&D, and Production) to procure the documents and to develop the documents required for compilation of API DMFs.
- Attending calls/Meetings with marketing teams, customers and plants regarding regulatory related issues as and when required.
- Development of DMFs for registration of products in countries like US, Europe, Brazil, China, Russia markets.
- Collecting, collating and evaluating scientific data received from plant/R&D.
- Responsible for timely planning, coordination and submission of API DMFs/deficiencies in EMT markets.
- Review of documents and compilation, identifying gaps, ensure suitability, acceptance etc.
- Guidance to cross-functional teams and team members on EMT regulatory strategy and regional regulatory requirements.
- Timely quality response to external customers on technical queries and requests.
- Life Cycle management of the products.
- Maintain compliance with the regulatory requirements.
Employment Type: Full Time, Permanent
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Anonymous · Banking Operations
in Hyderabad/Secunderabad
good
low salary and benfits
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