Genpact
Hiring Technical Associate - Regulatory Affairs ny graduate/Post graduate
degree in Pharmacy / Science
Responsibilities
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
Qualifications
Minimum
qualifications
Any
graduate/Post graduate degree or equivalent with a good academic record
Preferred
Qualifications / Skills
Pharmacy/Science
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