Job Title : Regulatory Coordinator - Regulatory Affairs CMC (India) Dept. : R&D/GRA Line Manager Job Title : Lead - Regulatory Affairs CMC (India) Job Purpose : The purpose of this role is to support CMC product responsible in executing CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products. Key Responsibilities : - Responsible for CMC regulatory matters relating to registrations and/or maintenance of business activities (including variations and renewals) for assigned product portfolio, such as mentioned below, - Accomplish and assist CMC product responsible in carrying out - administrative- tasks - Work towards improving quality of the information available in our databases - Support Internal Compliance checks: review of the PROTRAC (internal tracker which monitors CMC has completed all the steps from WI/ SOP till dispatch date in OPAL) on fortnightly basis. - OTC Docs Operational support : New account creation & access to TD cabinet. Resolve or support the resolution of any TD account related user challenges. Proposing, discussing & Testing of new upgrades in OTCDocs, running IQ OQ PQ, etc. in future it would be for Veeva. - Update standard requirement table & assist in archiving the CMC/ Regulatory surveys - Support the baseline/ Eurasia dossier by creation of the CMACs / TMACs/ Normative documents/ etc. - Follow-up with key/ major LOC in discussion (as necessary for submissions impacting business continuity): For OPAL update on submission / approval dates. For ex. For GREEN / Exit NVS project. - Interacts with colleagues in other global functions (e.g. Tech Excellence and Supply Chain) and Regulatory Affairs sub-functions to deliver high quality CMC dossiers, documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance. - Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls. - Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls. - Provide consolidated regulatory input into multi product/multiple manufacturing site RADARs by coordinating with product responsible for CMC changes impacting cross category products. - Coordinate to prepare and share projected CMC dispatch plan across categories to LOCs. - Coordinate to prepare and maintain the monthly deliverable matrix for CMC activities (e.g. contribution to innovation and PLC CMC support; RADARS, HAQ, Renewal). - Coordinate to maintain the update version of manufacturing site specific documents e.g. GMP and manufacturing authorization. - Coordinate to support the product responsible for cross category administrative changes. - - Review of the EDQM's database for CEP- . Knowledge/ Education / Previous Experience Required : 1. Minimum Level of Education : - Degree in a pharmaceutical or life science or equivalent regulatory experience Area of Specialization : - Science, Life Sciences - Medicinal/Medical Device/Cosmetic Regulation\ Why is this Level of Education Required? - Ensures basic level of scientific/regulatory understanding 2. Preferred Level of Education : Degree in a pharmaceutical or life science or equivalent Area of Specialisation : Life Sciences Why is this Level of Education Preferred? - Ensures basic level of scientific/regulatory understanding Job-Related Experience : Minimum Level of Job-Related Experience required : - 1-5 years- regulatory affairs experience in systems, regulatory information management, compliance and ideally OTC experience Why is this Level of Experience Required? - To have fundamental knowledge related to work

Hyderabad

GlaxoSmithKline - Coordinator - Regulatory Affairs 

GlaxoSmithKline - Coordinator - Regulatory Affairs  ,Job Description for GlaxoSmithKline - Coordinator - Regulatory Affairs  in GSK in  Hyderabad for (1-5) years of experience. Apply Now!

Job Description for GlaxoSmithKline - Coordinator - Regulatory Affairs  in GSK in  Hyderabad for (1-5) years of experience. Apply Now!