Regulatory Affairs Specialist

Ready to shape the future of work?

At Genpact, we dont just adapt to changewe drive it. AI and digital innovation are redefining industries, and were leading the charge. Genpacts AI Gigafactory, our industry-first accelerator, is an example of how were 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 thats 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 Assistant Manager/ Manager Regulatory Affairs, CMC and labelling

In this role Candidate should have experience in CMC and compliance services. Driving transformation and improving regulatory compliance with domain expertise and digital technology

Responsibilities

Preferred Qualifications/ Skills

Responsible for handling client-based requirements for new product registrations, pre-approval and post-approval submissions.

Compilation and submission of the technical documents for Consumer health care products within stipulated timelines.

Authoring of Quality Overall Summaries (QOS) and Module 3 CTD sections with reviewed and compliant data.

Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.

Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.

Preparation of Quality Overall Summaries (QOS)

Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.

Qualifications we seek in you!

Minimum Qualifications

B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.

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.

Lets 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 'starter kit,' paying to apply, or purchasing equipment or training.