Vacancy for Regulatory Affairs at Genpact Limited
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. Genpact invite application for Regulatory Affairs post interested candidate can apply for a position through a bottom link
Company: Genpact Limited
Post: Lead Associate – Regulatory Affairs
The Role demands a highly qualified professional who can provide guidance 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 as other associated regulatory projects
• Conduct timely project-specific training & meetings for the smooth running of the project and responsible for the overall management of the project
• Preparation of Bi-weekly Project Updates for Governance meetings with the 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 the preparation of Invoices
• Identify areas for improvements on the 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 member’s project performance, perform appraisals reviews and sharing constructive feedback, etc.
• Any Graduate / Post Graduate
• Pharmacy / Science
• Analytical Bend of Mind for Client reporting & dashboards.
• Ability to engage with people immediately & form relationships across all levels of business.
• Team Management & leadership skills and Proficiency.
• Excellent project management skills.
• 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 supervisor’s performance.
Qualification: B.Pharm, M.Pharm, M.Sc, B.Sc
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area: Regulatory Affairs
End Date: 30th November 2020