Specialist - Regulatory Affairs - Operations
Ready to turn bold ideas into real-world impact?
At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a robust partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run.
Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.
Job Description
Support through a number of regulatory functions specific to post-approval, lifecycle management capacities which includes –
Provide scientific inputs and actively involved in RA CMC strategic discussions
Monitor assumptions, risks and dependencies
Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:
Provide of regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country and regulatory procedure per country) and regulatory strategy
Provide tracking list and review documentation
Dispatch final documentation package to Local Regula