Job description

JOB DESCRIPTION:

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

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.