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
• 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 the submission content plan are accurate 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 onboarded team members.
• Maintain the record of the country profile sheet of Renewal publishing.
• Supervising updates of a new regulatory requirement for publishing.
• Ensure adherence to the specific project specifications or standards throughout the lifecycle of submissions.
• Conducts performance appraisals. Provides measurable feedback to assigned personnel and suggestions for improved performance. Formulates and implements employee corrective actions as needed. Should be able to coach, mentor and help all his/her direct reports to be motivated and engaged to grow their career with Genpact. Assists in interviewing and assigning new personnel as vital
Candidate Profile
Any graduate / Post graduate degree or equivalent with a good academic record
Preferred Qualifications / Skills
Pharmacy / Science
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 : 30th July, 2020
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