Submission Publisher

            TCS is hiring for Submission Publisher!!!

Job Location – Mumbai/Pune/Bangalore

Experience Range – 5 to 13 Years

Educational Qualification(s) Required – Any Life Science Graduate

Roles & Responsibilities:-

• ·         Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision
• ·         Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing)
• ·          QC electronic and paper submissions to ensure compliance with company and agency requirements. Job Description of Regulatory Submissions Publisher Page No.2 of 4
• ·         Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into c onsideration special requirements and needs;
• ·         Determine the scope of the electronic publishing requirements for the dossier
• ·         Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan
• ·         Participate in special projects and process improvement initiatives.
• ·         Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ