Company Name

GENPACT ( Mumbai )

Job Description

• Job Description:
  • Ready to shape the future of work
  • At Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges.
  • If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that's shaping the future, this is your moment.
  • Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
  • Inviting applications for the role of Lead Consultant Regulatory Affairs, Labelling for USA market
  • In this role Candidate should have experience in labelling regulation and requirements for US market including good knowledge of CCDS, Non-CCDS and Annual reportable labelling changes. Management process for Product website labeling changes, Editorial labeling changes, Labeling content development (PM and packaging components), including: CCDS updates and associated label negotiation and HC mandated label updates. Also, candidate should have hand on experience of labelling tools.
  Responsibilities:
  • Change management process of CCDS, Non-CCDS and Annual reportable labelling changes.
  • Analysis of competitor information (e.g. labels, approval packages) for regulatory policy projects and/or labelling projects
  • Escalate, notify and resolve any issues that may impact final labelling submission.
  • End to end responsibility of labelling for product registered in US market.
  • Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions.
  • Qualifications we seek in you!
  • Minimum Qualifications
  • B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
  • Preferred Qualifications/ Skills
  • Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
  • Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
  • Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.
  • Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
  • Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
  • Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
  • Depending on experience level, mentor newly hired staff or lead a team of junior staff.
  • Flexibility in responding to changing priorities or dealing with unexpected events.
  • Capability to handle multiple priorities and balance work to achieve business goals.

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