M-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 Management.
This program is intended to support client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules, biologics and combination products.

Responsibilities
• Responsible for leading and executing CMC regulatory strategies for assigned post‑approval pharmaceutical products in alignment with global regulations, guidance and defined regulatory strategies, including preparation and critical review of data and documents required for post‑approval CMC submissions and lifecycle management.
• Accountable for authoring, reviewing, and coordinating CMC documentation to support worldwide post‑approval changes and lifecycle activities (variations, supplements, amendments) and responses to health authority questions for commercial products per established business processes and systems.
• Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
• Collaborate effectively with cross‑functional teams (e.g., QA, QC, manufacturing, supply chain, packaging, device, and analytics), CMOs, and external partners to track and close out documentation gaps, compliant execution of change management, and conduct all activities with an unwavering focus on regulatory conformance.
• Ensure timely approvals for the submissions and Product supply continuity.
• Deliver all regulatory milestones for assigned products across the product lifecycle.
• Strong experience in CMC requirements for small molecule/biologic products.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrates strong written and verbal communication skills, including the ability to translate complex technical concepts into clear regulatory justifications and to influence decision‑making in cross‑functional and global forums.
• Shows sound understanding of related technical disciplines (such as pharmaceutical manufacturing, analytical testing, quality assurance, and quality systems) and applies this knowledge when defining regulatory strategies and compiling CMC dossiers.
• Proven ability to identify regulatory risks and opportunities, generate innovative yet compliant solutions to issues, and collaborate effectively with internal and external partners to align on regulatory pathways.
• Active participation in departmental and cross‑functional continuous improvement initiatives such as enhancement of templates, processes, systems; maintenance of standard operating procedures and internal guidelines etc.
• Demonstrates flexibility and resilience in managing changing priorities, unforeseen regulatory queries or health authority expectations, and time‑sensitive projects, while maintaining accuracy and compliance.
• Exhibits strong leadership, stakeholder management, and interpersonal skills, including mentoring junior colleagues and representing CMC regulatory function in project and governance meetings.
• Possesses advanced working knowledge of MS Office and relevant regulatory/quality IT systems (e.g., document management, Veeva Vault, RIMS, and tracking tools etc.) to efficiently prepare, manage, and archive CMC regulatory documentation.
• Demonstrates effective leadership, communication, interpersonal and negotiating skills.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Experience:
Relevant experience in CMC tasks and related aspects.
Qualifications we seek in you!
Minimum Qualifications
Master’s degree required in Pharmacy, Science, or related field with atleast 7 years of global Regulatory CMC experience.
Language: English

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.