Specialist - 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 candidates for Specialist - 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 of small molecules/ pharma, large molecules/ biologicals, etc.
Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management submissions under 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.
Understanding of job responsibilities & processes of cross-functional teams, manufacturing sites, Quality Assurance, Quality control, etc. Prior experience in these departments is preferable.
Experience in RA/ QA/ QC system and tools like SAP, documentum, Veeva, LIMS, spotfire, Power BI, etc is preferrable.
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 to 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.
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 colour 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.

Work arrangement
Hybrid