Technical
Associate - Regulatory Affairs- @ GENPACT
nviting applications for the role of Technical Associate,
Regulatory Affairs
You’re responsible to manage all activities in publishing,
Dispatching and archiving of global submissions (Renewals, Annual Reports, PA
Changes.)
Responsibilities
The Role demands for a self-driven Individual contributor who
will be responsible for all the activities related to –
Publishing of Renewals, Baseline Renewals for EMEA, ASIAPAC,
LATAM etc.
Publishing submissions using liquent insight publisher,
Extend and validating submissions using insight validator, Global summit,
Lorenz validator.
Ensure Documents provided in submission content plan are
correct through RCAM application.
Annual Report Submission publishing, Quality checks and
dispatch it through FDA ESG Gateway.
Preparation of work instruction guide.
Conducting training of new on boarded team members.
Maintain the record of the country profile sheet of Renewal
publishing.
Tracking updates of a new regulatory requirements for
publishing.
Ensure adherence to the specific project specifications or
standards throughout the lifecycle of submissions.
Should manage publishing task – initiation, plan, execute,
control and close assigned projects.
Qualifications
Minimum qualifications
Any Graduate/Post Graduate
Preferred Qualifications / Skills
Pharmacy/Science
TO APPLY CLICK HERE
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