FDA- Loan Licensing- Corporate Affairs | Cipla

Job Purpose:

1. Prepare and track the state FDA licence applications as per FDA guidelines for Cipla Contract Manufacturing Organizations (CMO) sites for existing products as well as new products to support in achieving on time Licence approval.

2. Tracking the new products Licences in Product Management Administrative (PMA) system and arranging documents from internal stakeholders required for Cipla Loan Licence & Own Licence applications purpose, to meet launch date of new products.

Accountabilities:

1.Prepare FDA licence applications for Fresh / Renewal / Additional products as per the format of respective state FDA departments and arrange to submit the same to respective FDA offices for getting on time approval of Licences.

• Prepare FDA Licence application for Fresh / Renewal / Additional products by compiling all the necessary documents as per the format of the respective State FDA along with supporting documents required for the approval FDA Licences.
• Send the application to respective Loan License (LL) Unit persons for submission at FDA department.
• Keep record and track of the applications submitted at various State FDA departments.

2. Track new products licence communications which are released by R&D department in online PMA system and monitor the same in coordination with the internal stakeholders to obtain new product licence approval at the respective unit to meet launch date of new products.

• Check R&D communication of new product with respect to Label claim, Therapeutic dose & Pharmacopeia Status
• Coordinate with internal stakeholders for technical documents and other references required to be submitted with licence application
• Forward R&D formula along with technical supporting documents and provide reference documents to Manufacturing Unit to be submitted with Licence application to the State Licensing Authority.

3. Arrange Working Standard & Method of Analysis as and when required by FDA Testing Laboratories in various State in India for Cipla products in order to support FDA Labs for on time analysis of Cipla products samples collected by FDA departments.

• Collecting Working Standard (WS) & Method of Analysis (MOA) from internal stakeholders and sending the same to respective FDA Laboratories for analysis of samples collected by FDA departments.
• Confirm the stability status about quality of respective product samples with QC department before sending method of analysis to FDA Labs.
• Maintain track record of the above.

4. Keep record of the Debit Notes raised by CMO sites and keep track of the same by

co-ordinating with Accounts department for the release of the payment of FDA Fees.

• Receive Debit Note from Contract Manufacturing Organizations (CMO) site and verify the fees paid and forward Debit Note to respective Accounts Department & Keep record of the same.
• Keep track with Accounts department for on time release of payments of FDA fees.

5. Controlled substances and Narcotics Destruction

• Coordinate for documents and submit the same for destruction of controlled substances and narcotics destruction.
• Follow up with concerned officials to ensure its timely approval and destruction.