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
• Monitor and develop continuous improvement proposals on the processes
• Maintain a staff of adequately skilled resources to meet deliverables
• Communicate issues and resolve them in an appropriate time frame
• Ensure adherence to agreed-to work practices
• Meet established submission timelines and quality standard.
• Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labelling
• Ensure collection of metrics
• Improve speed to minimize the cost
• Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
Candidate Profile
• Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
• Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
• Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required
• Must be able to construct a Company Response (MAH response) for health authority questions
• Masters in Life Sciences
• Understanding of key regulatory and Labeling principles and SOPs
Additional Information
Qualification : Masters in Life Sciences
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th July 2024
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