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 Senior Specialist-Regulatory Affairs Operations

**Work Location**: Hyderabad/Mumbai/Delhi NCR(Gurgaon, Noida)

Shift- Flexible

Responsibilities:

- Project management of dossier compilation, ensure transparent cross-functional planning and tracking of the compilation process.
- Operational execution of submission dossier preparation according to specified content plan with instructions.
- Establish, maintain, and adhere to Submission Project Plan timelines agreed upon as a team: Identify documents on the critical path.




- Support and Review of approved submission documents with submission content plan.
- May lead submission team meetings and through positive relationships with contributors/partners work to resolve issues (e.g., with timelines, document submission readiness, etc.) and ensure priority conflicts, resource issues and deviations from the dossier plan are identified and resolved.
- Maintains up-to-date knowledge of registration dossier requirements (e.g.: format and structure of submission dossier) and applies same to submissions to ensure compliance with regulatory agency regulations and interpretations.
- Communicate changes/critical updates during tracking team meetings to team members and Escalation of issues if timelines are at risk to be delayed.
- Participate in Technical Quality Review for Modules 1-5 for final approval for utmost quality and sign off for on-time dispatch to Health Authorities
- Educate all authors and reviewers on use of ISI Toolbox / Adobe Acrobat for technical QC / how to perform a technical QC.
- Frequent exchange and close collaboration and support with GRSs
- Coordinate the submission process from planning through dispatch.
- Provide overall management for production, assembly, and publishing.

Education Qualification:

- Bachelorsin Health Administration,
- Bachelorsin Healthcare,
- Bachelorsin Pharmacy,




- Mastersin Public Health, Mastersin Regulatory Affairs

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 Prospect 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.

📌 Senior Specialist - Regulatory Affairs - Operations (Mumbai)
🏢 Genpact
📍 Mumbai