Lead Consultant, Regulatory Affairs!

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 Lead Associate/Lead Consultant, Regulatory Affairs! 

Responsibilities: 

• Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.  
• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under direction of team scientists. 
• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.  
• Able to prioritize & execute the project according to the project plan/timelines/schedules.  
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels. 
• Understanding of job responsibilities & processes of cross-functional teams, manufacturing sites, Quality Assurance, Quality control, etc. Prior experience in these departments is preferable. 
• Experience in RA/ QA/ QC system and tools like SAP, documentum, Veeva, LIMS, spotfire, Power BI, etc is preferrable.