Description
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 adaptable in timings and available for teleconferences as per US te

📌 Senior Executive, Regulatory Affairs (Ahmedabad)
🏢 Amneal
📍 Ahmedabad