Job description:

Responsible for delivering and driving high quality submissions by self and the team in compliance with technical requirements from regulatory authorities.Responsible for fixing/guiding the team to fix/resolve any errors/challenges/roadblocks to ensure quality output to the HA – Submissions troubleshootingDrive first time right approach by educating the team and upstream workstreams on the relevant activitiesCollaborate with other Operations team/other relevant stakeholders to work towards a common goal and drive and deliver quality outputsWork closely with the team to Identify value adds/process improvements in the process and deploy the same for efficiency gainProactively work with the team to identify gaps/errors and liaise closely with the affiliates/Regional leads/any relevant key stakeholders to close the same through offering solutionsWork on work load versus resource mapping for an optimized resource managementManage the Publishing workflow to acknowledge and deliver timely submissions to key stakeholdersAwareness, equip and adaptation of self and the team to all the change in regulations across the countriesActively involved in testing of any new implementations or upgrades of the tools used in the organizationTrain the team and also the end user through train trainer program on the systems for Publishing suiteOptimize the cost of tickets through screening for any end user related mistakes before raising the ticketBe actively involed in tecnical discussions with ArisG for Publishing related queries to suggest or challenge on feature functionalties of Publishing suiteConduct or actively contribute towards kick off meetings of  eCTD implementation in a new country

Technical Competency and Development

Work as an SME for the team and affiliates in regard to the relevant workstream processesDeeper understanding of the of processes across product line – Pharma and VaccinesWork towards competency enhancement of the team with constant touch baseDevelop a backup for self to manage any technical queries, develop simplified work guide which will help use the same as reference materialAn expert in e CTD concepts and trouble shootingExposure to markets – RoW (EM), EU, (US - would be good to have)Exposure to varied Publsihing tools to idetnify white space and suggest optimization

Minimum Experience/Training Required:

A minimum of 8 - 10 years of experience in Submission publishing, Regulatory Affairs