Lead consultant Labeling Regulatory affairs.

3 weeks ago

Mumbai, India Genpact Full time

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing., People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. 
Welcome to the relentless pursuit of better.
Inviting applications for the role of Lead consultant Labeling 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
• Liaise with key interfaces on project requirements to ensure timelines are mutually understood.
• Drafting responses to MAH for Health Authority queries.
• Identify discrepancies/issues in local implementation of corporate labels.
• Lead team for timely deliverables.
• Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Sanofi communication/collaboration tools. 
• Maintaining updates related to labeling guidelines and regulations as they pertain to the development/maintenance of CCDS, US, EU and ROW labeling.
Minimum Qualifications and Experience 
• Masters in Lifesciences or experience in regulatory Affairs/Labeling or equivalent 
• Knowledge of the principles and concepts of Labeling
• 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

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