Work as Technical Associate in Regulatory Affairs at Genpact Limited | M.Pharm, M.Sc, B.Pharm
Post : Technical Associate – Regulatory Affairs
• 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
Any graduate / Post graduate degree or equivalent with a good academic record
Preferred Qualifications / Skills
Pharmacy / Science
Qualification : B.Pharm, M.Pharm, M.Sc, B.Sc
Location : Mumbai
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th July, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube