Genpact india has released the job of Regulatory Affairs for the post technical associate. Science graduates B.pharm / M.pharm / M.Sc etc may apply for this post. Find the complete details below.
Job Title: Technical Associate – Regulatory Affairs
Job ID: CPG016635
Job Location: Mumbai, Maharashtra
Any Graduate/Postgraduate degree or equivalent with a good academic record
Preferred Qualifications / Skills
You’re responsible to manage all activities in publishing, Dispatching and archiving of global submissions. The Role demands 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 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.