Senior Manager - Regulatory Affairs
- Genpact
- 5 to 9 Yrs
- Maharashtra
- 7 months ago
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Job Description
- Genpact (NYSE: G) 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. Inviting applications for the role of Senior Manager- Regulatory Affairs! In this role, you will be expected to work on deadlines, in a fairly high-pressure business environment while being a good great teammate. Responsibilities 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 Qualifications we seek in you! Minimum qualifications 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 Preferred qualifications Should be open to work in any shift as per the business requirement JobSenior Manager Primary LocationIndia-Mumbai ScheduleFull-time Education LevelBachelor's / Graduation / Equivalent Job PostingJun 6, 2025, 6:50:50 AM Unposting DateOngoing Master Skills ListOperations Job CategoryFull Time,
Employement Category:
Employement Type: Full timeIndustry: BFSIRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Senior Manager - Regulatory AffairsContact Details:
Company: GenpactLocation(s): Maharashtra+ View Contact
Keyskills: Regulatory Affairs Continuous Improvement Staff Management Communication Metrics Collection Problem Solving Life Sciences SOPs
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