Manager 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 Manager Regulatory Affairs-CMC Documentation
This role directly contributes to the Company's revenue growth and margin by leading operational teams in Regulatory Space. Specifically, the Senior Manager is required to:

Responsibilities
.Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation.
.Coordinate with manufacturing and quality teams to ensure accurate and timely data for regulatory submissions.
.Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports
.Experienced in authoring assessment reports and Part2/ Expert reports for Dossiers
.Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
.Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Qualifications we seek in you!
Minimum Qualifications

Preferred Qualifications/ Skills
.Manage execution / authoring of CMC documentation (Module 1, 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
.Knowledge of regulatory guidelines and relevant applications.
.Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
Why join Genpact
.Be a transformation leader - Work at the cutting edge of AI, automation, and digital innovation
.Make an impact - Drive change for global enterprises and solve business challenges that matter
.Accelerate your career - Get hands-on experience, mentorship, and continuous learning opportunities
.Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
.Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress
.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.