Following will be the responsibilities of position holder:
Compilation of ANDAs and 505(b)(2) applications (pIND meetings, IND submissions, Brand Name submissions) with USFDA
Experience in submission of pre-ANDA meetings for complex products with USFDA
Review of DMFs of complex peptide drug substances
Ensure timely response submission for ANDA deficiencies i.e., IR, CRL and DRL
Ensure Labeling compilation, including SPL and side by side comparison against RLD labels with highlighted annotation of changes
QBR compilation for drug substance and drug product; Sterility assurance QBR
Experienced with handling drug device combination regulations and understand the requirements for submission of Threshold Analysis report and Human Factor Engineering studies protocols and reports. Review and approve of Design History File
Controlled correspondence submission with the regulatory authorities for bioequivalence recommendations & inactive ingredient levels and Q1 and Q2 sameness evaluation which are essential during the product development stage before the submission of an application
Supplements filling for addition of alternate facility and CMC related changes, e.g., PAS, CBE-30 and CBE-0
Life cycle management of products & approving the change controls and ensure product continuity through filing and timely approvals of supplements. Support the continuity activities through co-ordination with various stakeholders
Approval package compilation and provide support for lunching of the approved ANDA product
Ensure product compliance with respect to approvals and regulatory requirements
Tracker management-Maintenance of ANDA filing status, deficiency, approval, labelling and new launch status