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 troubleshooting
• Drive first time right approach by educating the team and upstream workstreams on the relevant activities
• Collaborate with other Operations team/other relevant stakeholders to work towards a common goal and drive and deliver quality outputs
• Work closely with the team to Identify value adds/process improvements in the process and deploy the same for efficiency gain
• Proactively 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 solutions
• Work on work load versus resource mapping for an optimized resource management
• Manage the Publishing workflow to acknowledge and deliver timely submissions to key stakeholders
• Awareness, equip and adaptation of self and the team to all the change in regulations across the countries
• Actively involved in testing of any new implementations or upgrades of the tools used in the organization
• Train the team and also the end user through train trainer program on the systems for Publishing suite
• Optimize the cost of tickets through screening for any end user related mistakes before raising the ticket
• Be actively involed in tecnical discussions with ArisG for Publishing related queries to suggest or challenge on feature functionalties of Publishing suite
• Conduct 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 processes
• Deeper understanding of the of processes across product line – Pharma and Vaccines
• Work towards competency enhancement of the team with constant touch base
• Develop a backup for self to manage any technical queries, develop simplified work guide which will help use the same as reference material
• An expert in e CTD concepts and trouble shooting
• Exposure 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