Job Description
Major purpose of the job:
Preparation of DMF, annual update and its submission to various regulatory authorities.
Preparation of Applicant's part CEP/DMF/ASMF and responses of various Applicant's parts as per customer requirements.
Preparation of LOAs, including CEP LOAS, to various customers and regulatory authorities.
Key responsibilities Area:
1. To compile and submit new DMF/ASMF/CEP to various health agencies such as the US, Europe, EDQM, ROW, etc.
2. To compile and submit amendments, annual reports, or revisions of DMF/ASMF/CEP to various health authorities.
To create and submit the applicant part of the CEP/DMF/ASMF as per customer requirements.
3. 4. To issue LOAs, including CEP LOAs, to various customers and regulatory authorities.
5. To provide accurate query responses to customers as quickly and efficiently as possible.
6. Prepare and submit timely declarations and other information and documents requested by customers.
7. To coordinate with the quality assurance, quality control, production, and R&D departments with respect to regulatory submissions.
8. To review and identify gaps in the documents required for regulatory submission, the same will be discussed with the concerned departments, and suggestions will be provided as per the current regulatory guidelines.
9. To coordinate with the marketing department with respect to customers and health agency requirements.
10. To identify gaps or common queries raised by a health agency and resolve after discussing with the reporting manager or team.
11. To discuss and participate in all routine work activities with seniors and colleagues
