Sr. Specialist - Regulatory Affairs - Operations 4C

Sr. Specialist - Regulatory Affairs - Operations Ready to turn bold ideas into real-world impact?  At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory , our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI , our breakthrough solutions tackle companies’ most complex challenges.   If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.    Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.  Get to know us at genpact.com and on LinkedIn , YouTube , X , and Facebook .

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