Genpact is a global professional services firm that makes business transformation real. We drive digital-led innovation and digitally-enabled intelligent operations for our clients, guided by our experience running thousands of processes primarily for Global Fortune 500 companies. We think with design, dream in digital, and solve problems with data and analytics. Combining our expertise in end-to-end operations and our AI-based platform, Genpact Cora, we focus on the details – all 90,000+ of us. From New York to New Delhi and more than 30 countries in between, we connect every dot, reimagine every process, and reinvent companies’ ways of working.
Post : Technical Associate - Regulatory Affairs
Job Description
• 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
Experience : +2 years
Qualification : B.Sc, B.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
ID : CPG013801
End Date : 25th October, 2019
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