Manager - Regulatory Affairs

Ready to build the future with AI At Genpact we don t just keep up with technology we set the pace 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 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 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 or Senior Manager Regulatory affairs- 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 Responsibilities Leading project teams providing technical guidance ensuring maintenance of team records and process-related documentation i e process maps job aids project trackers checklists etc 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 Ability to lead client meetings and managing project governance Deliver on agreed SLAs with clients at contract and account project level Meet all monthly reporting business metrics KPIs requirements and manage internal control processes Planning the project by understanding the client needs channelizing appropriate resources managing project deliverables training team as well as client on a need-basis and providing solutions in real time Improvise the process and outcomes by implementing continuous improvement initiatives leveraging six-sigma methodologies RPA AI opportunities for harmonization simplification and automation Assess and communicate potential regulatory risks and propose mitigation strategies Ability to prioritize execute the project according to the project plan timelines schedules Ensure established policies and procedures of the organization client are followed and ensure compliance Work with cross-functional teams to track and follow up outstanding documentation coordinate project status report to stakeholders using different communication channels Contribute to draft Request for information and or Request for proposals for new client business opportunities Provide inputs to project regulatory strategies by performing assessments of CMC changes identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner Strong listening skills Superior attentiveness to detail has a strong regulatory background Demonstrated understanding of related fields e g pharmaceutical manufacturing analytical testing and quality assurance Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders Demonstrated flexibility in responding to changing priorities multi-tasking and dealing with unexpected events Demonstrated effective leadership communication and interpersonal skills Qualifications we seek in you Bachelor s or master s degree required in science engineering or related field advanced degree preferred Why join Genpact Lead AI-first transformation - Build and scale AI solutions that redefine industries Make an impact - Drive change for global enterprises and solve business challenges that matter Accelerate your career Gain hands-on experience world-class training mentorship and AI certifications to advance your skills Grow with the best - Learn from top engineers data scientists and AI experts in a dynamic fast-moving workplace Committed to ethical AI - Work in an environment where governance transparency and security are at the core of everything we build 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 140 000 coders 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