specialist_regulatory submissions in chennai

posted
contact
randstad india
position type
temporary
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posted
location
chennai, tamil nadu
function
Pharma, healthcare & lifesciences
position type
temporary
experience
5
reference number
56191
contact
randstad india

job description

specialist_regulatory submissions in chennai

PL of Publishing team, assigning of publishing tasks to the team members andupdate the trackers. • To Provide training and mentorship to the team. •Activities includes publishing of submissions in eCTD, NeeS and Paper formatsfor different markets like US, HC, EU, GCC, AU and South Africa, NeeS andPaper format for rest of the world countries using eCTDManager. • Creation ofBinders and assigning of workflow in Veeva Vault. • Archiving eCTD submissionsin Veeva Vault and updating Veeva RIMS activities. • Monitoring the RIMSactivities. • To prepare, review the training material. • To organize themeetings with the clients to understand the client requirements and inform thesame to the team to reach client expectations. • To discuss with the client onany ongoing issues, forecast of the publishing activities. • To monitor the QClogs and prepare final logs to prepare quality metrices. • To give monthlyupdates to the management on publishing activities

skills

submissions

qualification

MS/M.Sc(Science)