Specialist - Regulatory Affairs - Operations 4A

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 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.     .

Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs Certifications Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of