Department - Regulatory Affairs

Function - Post Approval

Dosage - Injectable/Sterile

Job Description -

- 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

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