Regulatory Affairs API

Job Roles:

Preparation of Drug Master File in compliance with

Regulatory standards, guidelines and procedures.

Performing gap analysis for the existing DMF against the

most updated documents in the site for all the commercial

drug substance.

Responsible to ensure all the technical documents in the

DMF are adequate and thoroughly reviewed before

submission.

Narcotic substances inline with NDPS act-Quarterly

Returns of Narcotic drugs, Monthly balance review of

Narcotic drugs, Quarterly Returns of controlled substance,

Narcotic drugs Quota license renewal