Require Technical Associate in 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.
Post : Technical Associate – Regulatory Affairs-CPG020636
• Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
• Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory results for assigned products across the product lifecycle
• Identify and communicate potential regulatory issues to GRACS CMC, as needed
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Proven ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
• Proven flexibility in responding to changing priorities or taking care of unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Bachelor’s degree in pharma / Science
• Strong financial analytical skills and problem solving skills.
• Effective communicate in writing and verbally to senior management.
• Experience in balancing customer facing role and work assessments.
• Self-starter and have analytical, prioritization skills
• Ability to balance customer governance meetings
Qualification : B.Pharm, BSc
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affair
End Date : 30th March, 2021