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 rapid-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 strong 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
Inviting applications for the role of: Lead Associate Publisher for US market Regulatory Affairs.
You should have experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent Docu Bridge etc.
Responsibilities:
- In this role you will be responsible for:
- The Role demands for a publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment the Person will be responsible for all the activities related to.
- Publishing and performing technical validation of e CTD for US submissions.
- Performing final technical quality review.
- Dispatching submission to the relevant autho

📌 Lead Associate – Regulatory Affairs (Mumbai)
🏢 Genpact India
📍 Mumbai