Job for M.Pharm, B.Pharm as Regulatory Affairs Associate at Genpact Limited

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Genpact Limited, a global leader in business process and technology management services, leverages the power of smarter processes, smarter analytics and smarter technology to help its clients drive intelligence across the enterprise. Genpact’s Smart Enterprise Processes (SEP) framework, its unique science of process combined with deep domain expertise in multiple industry verticals, leads to superior business outcomes.

Post : Technical Associate - Regulatory Affairs

Job Description
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.

Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc, B.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 15th November, 2019


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