Technical Associate - Regulatory Affairs @ GENPACT, Pharmacy/Science

Technical Associate - Regulatory Affairs @ GENPACT

With a startup spirit and 80,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.

 Inviting 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

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