Job Responsibility: Regulatory Affairs

* Must have expertise/prior experience in Sterile
(Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic
sterilization or Terminal sterilization or both techniques.

* 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 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 flexibl

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