Sun Pharma- Walk-In Interview For Regulatory Affairs On 3Rd December 2023

Sun Pharma- Walk-In Interview For Regulatory Affairs on 3rd December 2023,Job Location: R&D BarodaDate: Sunday, 3rd December 2023, Time: 9.30 am -1.00 pmVenue of Interview : Sun Pharmaceutical Industries Ltd – Sun Pharma Road, Tandalja – Baroda - 390016Department:Regulatory Affairs APIQualification:M.Sc-ChemistryGrade:ExecutiveExperience:2 - 4 yearsBrief Job Description:Minimum 2yrs of experience in regulatory affairs/quality assurance of API Plant or corporate. Good understanding of basic DMF compilation and lifecycle management requirement. Good understanding of Change control and related submission requirement2) Department:Regulatory Affairs Formulation - USQualification:M.PharmGrade:Executive / Sr.ExecutiveExperience:3 - 6 yearsBrief 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 agencies4)) 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 gateway3) Department:Regulatory Affairs Formulation - US (Labeling)Qualification:B.Sc/ B.Pharm/ M .PharmGrade:Sr Officer / ExecutiveExperience:1-6 yearsBrief Job Description:1. 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 claims2. 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 amendment3) Life Cycle Management : Track RLD labeling changes. Initiate labeling revision activity as per RLD label revision/ safety labeling change ?SLC? notification from FDA4) Department:Regulatory Affairs Formulation - US (eCTD)Qualification:B.Sc/ B.PharmGrade:1-6 yearsExperience:Sr Officer / ExecutiveBrief Job Description: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.#J-18808-Ljbffr