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Sun Pharmaceutical Walk-in drive @Baroda for multiple opening in Regulatory Affairs (API & Formulation) department
Walk-in drive @Baroda
Department: Regulatory Affairs API, Regulatory Affairs Formulation-US, Regulatory Affairs Formulation-US (Labeling), Regulatory Affairs Formulation-US (eCTD)
Qualification: B.Sc/ B.Pharm/ M Pharm
Designation: Sr Officer/ Executive
Experience: 1-6 years
Brief Job Description: 1) Review all data and documents related to product registrations for various health authorities. 2) Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. 3) Prepare responses to deficiency letters received from various agencies. 4)) Maintain life-cycle/post approval changes for drug product registration dossiers. 5) Provide regulatory support to cross functional departments. 6) eCTD compilation, verification and submission through electronic gateway
Original Application submission: Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve-outs based on patents and exclusivity claims 2. Labeling Query responses and Patent Amendments: Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission. Review of patent amendment 3) Life Cycle Management: Track RLD labeling changes. Initiate labeling revision activity as per RLD label revision/safety labeling change (SLC) notification from FDA
1) Regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements. (US and other advanced markets). 2) Electronic Document Publishing (i.e. PDF file preparation as per eCTD requirement, bookmarking/linking, compilation/publishing in software.
Job Location : R&D Baroda
Date: Sunday, 3rd December 2023, Time: 9.30 am 1.00 pm
Venue of Interview : Sun Pharmaceutical Industries Ltd – Sun Pharma Road, Tandalja – Baroda – 390016
Note: Candidates are requested to walk in with updated resume, last degree, PAN card, Aadhar card and current CTC proof at the venue. Disclaimer: Sun Pharma does not seek payment of any kind from any prospective candidate for employment or authorize any agency or any individual to collect or charge fees for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing Sun Pharma. Merely participating in any recruitment drive does not ensure job entitlement at Sun Pharma.
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