Submissions Publisher

TCS is Hiring - Submissions Publisher 

location: Mumbai, Pune, Bangalore

Role and 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.

➢  Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs;

➢  Maintain open and timely communication; and

➢  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.