Genpact looking for Regulatory Affairs Senior Manager

Genpact is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

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 labelin
• 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 : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : DRA
End Date : 20th July 2025