- Full Time
- Mumbai

Website Genpact Limited
Company Overview
Genpact Limited, a global leader in business process and technology management services, leverages the power of smarter processes, analytics, and technology to help its clients drive intelligence across the enterprise. Genpact’s Smart Enterprise Processes (SEP) framework, combined with deep domain expertise in multiple industry verticals, leads to superior business outcomes.
Job Description
Position: Senior Manager – Regulatory Affairs
Location: Mumbai
Industry Type: Pharma/Healthcare/Clinical Research
Functional Area: Regulatory Affairs
End Date: 30th July 2024
Key Responsibilities:
- Process Improvement: Monitor and develop continuous improvement proposals for regulatory processes.
- Team Management: Maintain a staff of adequately skilled resources to meet deliverables.
- Issue Resolution: Communicate issues and resolve them in an appropriate time frame.
- Compliance: Ensure adherence to agreed-upon work practices.
- Timeliness and Quality: Meet established submission timelines and quality standards.
- Global Collaboration: Participate in global teams to complete assignments and tasks related to labeling.
- Metrics Collection: Ensure collection of relevant metrics to measure performance.
- Cost Efficiency: Improve speed to minimize costs.
- Discrepancy Management: Identify discrepancies/issues in local implementation of corporate labels and contact affiliates for remediation actions.
Candidate Profile
- Regulatory Knowledge: Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of the Labeling Team’s purpose and objectives.
- Strategic Insight: Proven ability to understand regulatory implications of product strategy concerning product labels, assessment, and practical management of associated impacts.
- Team Collaboration: Ability to work well in cross-functional teams, exhibiting active listening skills and the confidence to guide decision-making for document content strategy.
- Public Speaking: Proficient in speaking publicly to senior management when required.
- Regulatory Response: Must be able to construct a Company Response (MAH response) for health authority questions.
- Educational Background: Masters in Life Sciences.
- Regulatory Principles: Understanding of key regulatory and labeling principles and Standard Operating Procedures (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
Join Genpact Limited and be a part of a team that drives intelligence across the enterprise through smarter processes, analytics, and technology. Apply now to be a part of our mission to deliver superior business outcomes.
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