Regulatory Affairs-API / Deputy Manager /Manager

As discussed below is the JD for EMT RA Positions:

1. Preparation and Compilation of DMFs in-line with regulations of Regulatory and Semi-Regulatory countries.
2. Supporting to the concerned Marketing department/teams in terms of providing appropriate documents.
3. 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.
4. Attending calls/Meetings with marketing teams, customers and plants regarding regulatory related issues as and when required.
5. Development of DMFs for registration of products in countries like Brazil, China, Russia markets.
6. Collecting, collating and evaluating scientific data received from plant/R&D.
7. Responsible for timely planning, coordination and submission of API DMFs/deficiencies
   in EMT markets.
8. Review of documents and compilation, identifying gaps, ensure suitability, acceptance etc.
9. Guidance to cross-functional teams and team members on EMT regulatory strategy and regional regulatory requirements.
10. Timely quality response to external customers on technical queries and requests.
11. Life Cycle management of the products.
12. Maintain compliance with the regulatory requirements