Must have expertise/prior experience in Complex Product (including Sterile
(Aseptic & Terminal), Nasal, Transdermal & Topical Dosage Forms) ANDAs and/or
NDAs.
· Compile, prepare, review and submit IND, NDA and ANDA submissions along with
associated Amendments to FDA with an overall objective to avoid major
deficiencies and contribute to get approval within the shortest timeframes
possible.
· Develop and implement CMC regulatory strategies for IND/NDA and ANDA
submissions, lifecycle management, and deficiency responses to ensure timely
approvals.
· Maintains full awareness of all regulatory activities on assigned projects and
ensures that project deadlines and performance standards for these projects are
established and met.
· Ensure high quality, compliance-driven submissions aligned with cGMP, ICH, and
FDA expectations. Drive first-cycle approval success, minimize deficiency rates,
and ensure “Right First Time” submissions.
· Prepare and finalize controlled correspondence as well as Pre-submission
meeting package (Pre-ANDA, Pre-IND,
Pre-NDA and EU scientific advisory meetings)
to FDA or EU on specific issues as needed for assigned projects.
· Ensure timely submission of all assigned projects. Work very closely with all
relevant departments at the time of product initiations, R&D; phase, NDA/ANDA
Execution and after initiation of stability to ensure availability of all
documents to ensure timely submissions.
· Assess the deficiency letter immediately after receipt from FDA, perform
in-detail gap assessment and discuss with superiors to finalize the strategy to
respond the deficiency.
· Evaluate post-approval change controls and formulates strategies for correct
filing categories, with minimal involvement of supervisor. Compile and submits
critical post-approval supplements, such as CBE, CBE-30 and PAS.
· Proactively raises major project issues to superior for resolution and
agreement.
· Be versatile in timings and available for teleconferences as per US team