• Responsible for Brazil, Korea, Russia and other ROW market
DMF related activities Current filings/ query responses and customer
support for Applicant DMF/ RP Filing and Query responses
Key Responsibilities:
- Ensure timely submission of CADIFA DMF and Expression of interest filing for Brazil as per schedule
- Ensure timely DMF submission of new projects to China and WHO Agency as per schedule
- Ensure timely DMF submission of new projects to Korea and Russia Agency as per schedule
- Review and ensuring timely submission of Korea Annual updates and Revision reports to Korean Agency
- Review of ANVISA ,other ROW agencies , Brazil customer and other ROW customers queries and provide timely response
- Ensure timely submission of Applicant part/ Technical package to
- customers and Restricted part submission to ROW agencies
- Life cycle management of product, record keeping, including maintenance, updation of DMF for ROW markets
- Notification regarding DMF amendments submitted to regulatory agencies to LOA ,LOC and DMF customers.
- Keep abreast of latest regulations, interpreting and understanding guidance and disseminating the information to all concerned