Genpact Manager - Regulatory Affairs Pharmacy/Science/ny
Graduate/Post Graduate
Manager - Regulatory Affairs-CPG015998
With a startup spirit and 90,000+ curious and
courageous minds, we have the expertise to go deep with the world’s biggest
brands—and we have fun doing it. Now, we’re calling all you rule-breakers and
risk-takers who see the world differently, and are bold enough to reinvent it.
Come, transform with us.
Are you the one we are looking for?
We are inviting applications for the role of
Manager, Regulatory affairs
In this role, you are encouraged to have good
knowledge of Planning and timely execution of product life cycle management
projects. We are looking for some who should be open to work in any shift as
per the business requirement.
Responsibilities
The Role demands for a highly qualified professional
who can provide mentorship to direct reports typically comprising of first line
managers and supervisors. Senior Manager will be responsible for all the
activities related to –
Planning and timely execution of product life cycle
management projects like Product License Renewals and Post approval CMC changes
Perform technical review or quality checks of
Product license renewals for EU & ROW markets for Small molecules &
Biologicals
Provide regulatory leadership as needed for
efficient management of product license renewal project as well other
associated regulatory projects
Conduct timely project specific trainings &
meetings for smooth running of project and responsible for overall management
of the project
Preparation of Bi-weekly Project Updates for
Governance meetings with client
Preparation and review of monthly project metrics
and bi-weekly dashboards
Perform review of team’s billable hours, approve
their timesheets and support in preparation of Invoices
Identify areas for improvements on current project
process and documentation of the same after successful discussion and
implementation
Meets client expectations on results output with
respect to project timeliness and quality accuracy
Responsible to evaluate team members project
performance, perform appraisals reviews and sharing constructive feedback, etc.
Qualifications:
Minimum qualifications
Any Graduate/Post Graduate
Adhere to our principles and values.
Time Management skills.
Organizational Skills
Team Management & leadership skills and
Proficiency.
Analytical Bend of Mind for Client reporting &
dashboards.
Ability to engage with people immediately &
build relationship across all level of business.
Takes Ownership of problems and drives solutions
Competence to build and effectively lead good
rapport across global project teams.
Providing Coaching & Feedback to enhance first
line managers and supervisors performance.
Preferred Qualifications / Skills:
Pharmacy/Science
Passion & confidence
Active listening & Resourcefulness
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