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Asst Manager/ Dy Manager - Regulatory Affairs API

Asst Manager/ Dy Manager - Regulatory Affairs API

Hetero Labs Limited

10 - 15 years

0 Lacs

Hyderabad / Secunderabad, Telangana Telangana India

Posted:17 hours ago| Platform: Foundit logo

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Skills Required

Regulatory Affairs Emt DMF

Work Mode

On-site

Job Type

Full Time

Job Description

Preparation and Compilation of DMF's in-line with regulations of Regulatory and Semi-Regulatory countries. Supporting to the concerned Marketing department/team's 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 DMF's for registration of products in countries like Brazil, China, Russia markets. Collecting, collating and evaluating scientific data received from plant/R&D. Responsible for timely planning, coordination and submission of API DMF's/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.