Job Description

Department - Regulatory AffairsFunction - Post ApprovalDosage - Injectable/Sterile -- Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. - 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.- Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs. - Ensure timely submission of all assigned projects.- Review / prepare documents which meet the requirement set forth by US FDA and accepted for review by FDA without query or RTR. - Evaluate change controls and formulates strategies for correct filing categories, with guida+nce from supervisor. Proactively raises major project issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS as and when necessary.- Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.- Prepare and finalize controlled correspondence to FDA on specific issues as needed for assigned projects.- 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.- Proactively raises major project issues to superior for resolution and agreement.- Be flexible in timings and intermittently available for t-cons as per US team schedule. - Evaluate final compositions for IIG and Proportionality similar criteria\'s and develop regulatory strategies to avoid acceptable for filing issues.- Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time.- Proof-read and approve all OTC and Rx product labeling components.Note - USA Market experience is must (ref:biojoby.com)

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