Job Description

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 , 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 , 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 and on , , , and .
We are inviting applications for the role of Lead Associate or Lead Consultant, Regulatory affairs.
Responsibilities:
Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
The core responsibility will be to review the authored documents, compare them with source documents, ensure there are no transcription or formatting errors, no quality errors, and ensure compliance with regulatory guidelines.
Maintaining the quality of documents through quality reviews ensuring "No Queries" received from Health Authorities
Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under the direction of team scientists.
Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Able to prioritize & execute the project according to the project plan/timelines/schedules.
Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).

• Ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders.
• Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Effective leadership, communication, and interpersonal skills.
• Advanced knowledge of MS Office.

Superior attentiveness to detail & has a strong regulatory background.
Qualifications we seek in you!
Minimum Qualifications
Bachelor's or master's degree required in science, engineering or related field (advanced degree preferred).
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 'starter kit,' paying to apply, or purchasing equipment or training.