Manager, Regulatory affairs.-LIF019289 Job in
- Genpact
- 3 to 7 Yrs
- Hyderabad
- 9 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 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. 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 Responsibilities Updating and maintenance of harmonized/regional labeling including artwork for inserts and packaging components Liaise with key interfaces on project requirements to ensure timelines are mutually understood. Liaise with Labeling Manager to understand nature of change, urgency, important information for affiliates and/or implementation Prepare global dispatch of core label information, including notice to affiliates Enter data into systems pre-dispatch and update systems with post-dispatch activities (Appian, Vault, Vista) Competitive labeling analysis as needed and/or requested Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Client communication/collaboration tools. Identify discrepancies/issues in local implementation of corporate labels Qualifications we seek in you! Minimum Qualifications / Skills Masters in Lifesciences or equivalent with more years of experience in regulatory Affairs/Labeling or equivalent Knowledge of the principles and concepts of Labeling, knowledge of the principles and concepts of Labeling, including generics, authorized generics, private labels, device/combination products, how to read and interpret HA regulations and guidance, and underlying SOPs Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions Must be able to construct a Company Response (MAH response) for health authority questions Preferred qualifications Excellent communication and PC skills Job Manager Primary Location India-Hyderabad Schedule Full-time Education Level Bachelor's / Graduation / Equivalent Job Posting Mar 20, 2025, 8:39:10 AM Unposting Date Ongoing Master Skills List Operations Job Category Full Time,
Employement Category:
Employement Type: Full timeIndustry: BFSIRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Manager, Regulatory affairs.-LIF019289 Job inContact Details:
Company: GenpactLocation(s): Hyderabad+ View Contact
Keyskills: Regulatory Affairs Project Management Communication Skills Data Management Analysis
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