Lead Consultant - Regulatory Affairs

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.

We are seeking a support for client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules, biologics and combination products.

Responsibilities

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 :

Manage and oversee support for renewals and post approval CMC commitment involving deliverables such as :

CMC management :

Interaction with competent authorities in the context of ASMF / DMF and CEP activities.

General tasks :

Experience :

Relevant experience in CMC tasks and related aspects.

Qualifications we seek in you!

Minimum Qualifications

Atleast Bachelor%27s degree required in for Pharmaceutical : science, engineering, or related field (advanced degree preferred).

Language : English

Why join Genpact

Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters : Up.

Let's build tomorrow together.Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military / veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a %27starter kit,%27 paying to apply, or purchasing equipment or training.