Senior Executive

About the role

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. To compile and submit new DMF/ASMF/CEP to various health agencies such as the US, Europe, EDQM, ROW, etc.

What you'll do

• Create and submit the applicant part of the CEP/DMF/ASMF as per customer requirements
• Provide accurate query responses to customers as quickly and efficiently as possible
• Prepare and submit timely declarations and other information and documents requested by customers
• Coordinate with the quality assurance, quality control, production, and R&D departments with respect to regulatory submissions
• Review and identify gaps in the documents required for regulatory submission, the same will be discussed with the concerned departments

What you need

• Regulatory affairs
• Quality control
• Any graduate