Lead Associate – 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.

We are inviting applications for the role of Lead Associate or Lead Consultant, Regulatory Affairs.
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) for commercial products, under the strategic direction of senior regulatory CMC scientists or product leads.
• Experienced in evaluating scientific and technical information to assess the merits and regulatory impact of proposed post‑approval changes, ensuring that rationales are clearly articulated, risk‑based, and fully supported by appropriate data.
• Able to prioritize, plan, and drive multiple CMC post‑approval projects in parallel, ensuring timely preparation, review, and submission of high‑quality dossiers in line with agreed project plans, regulatory timelines, and internal milestones.
• Works effectively with cross‑functional teams (e.g., QA, QC, manufacturing, supply chain, packaging, device, and analytics) to track and close out documentation gaps, coordinate on change implementation status, and provide clear, concise regulatory updates to stakeholders through appropriate communication channels.
• 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, RIMS, and tracking tools) to efficiently prepare, manage, and archive CMC regulatory documentation.

Qualifications we seek in you!
Bachelor's or Master’s degree required in Pharmacy, Science, or related field (advanced degree preferred) with around 5-10 years of global Regulatory CMC experience.

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.