Opportunity for Senior Manager in Regulatory Affairs at Genpact Limited

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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.

Post : Senior Manager - Regulatory Affairs

Job Description
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.

Candidate Profile
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

Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc, B.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th June, 2020

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