1) Should have sound knowledge of FDA documentation (Domestic and Exports).
2) Should have multi-tasking attributes and should have excellent communication skills to interact with FDA authorities / Overseas Customers.
3) Should be able to plan and execute the FDA activities as per requirements and should be flexible to manage the priorities.
4) Should be well versed with requirements / guidelines of local and other states FDA authorities.
5) Should have enough knowledge and experience of coordinating with FDA for new applications / renewal of applications pertaining to Loan mfg. license, NOCs, Test Licenses, Product Permissions, COPP, FSC, NSQ, WHO-GMP and other technical documents.
6) Should be responsible for supporting the regulatory dept. for timely availability of valid legal documents (i.e. notarization and/or attestation from Embassies/Consulates in India for different countries).
7) Should be responsible for preparation and timely submission of replies to queries raised by FDA authorities.
8) Should be responsible for providing supportive feedback related to FDA documents to the Marketing dept.
9) Key role in planning and executing all FDA related work at various stages.
10) Coordinate with facilities for data to support the regulatory team. Maintain records for the regulatory team. Support regulatory team with miscellaneous jobs (printing, follow-ups, typing).