Sr. Specialist - Regulatory Affairs - Operations 4C

Job description

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. Job Description Sr. Specialist (Band 4C), Data Support End User Expert – Veeva RIM The Sr. Specialist, Data Support End User Expert, is responsible for overseeing global regulatory master data management operations, ensuring data quality, compliance, and adherence to MDM standards within RIM systems. The role leads and supports the data management team, drives process improvements, manages client relationships and governance activities, and develops reporting metrics to ensure timely, accurate, and high-quality service delivery. Leveraging expertise in Regulatory Affairs systems, data governance, reporting, and Six Sigma methodologies, the individual enables operational excellence and continuous improvement across regulatory data management processes. Support Veeva Active Dossier Management by performing: • Dossier Lifecycle Oversight: Maintain a holistic, cross-market view of current, submitted, and superseded product documents using Veeva Vault Active Dossier. • undefined • Data & Process Automation: Oversee automated generation and calculation of dossier records linked to regional submissions, global content plans, and health authority interactions • undefined • Configuration & Maintenance: Manage Active Dossier templates, object lifecycles, and country-level generation rules within Veeva Vault. • undefined • Cross-Functional Support: Partner with regulatory authors, CMC teams, and submission managers to verify traceability and resolve document-type discrepancies. • undefined • Audit & Compliance Readiness: Ensure accurate tracking of local-language translations, source files, and status history across various international markets. • undefined Key Responsibilities: ·         Responsible for guiding the entry, updating, maintenance, and archival of data entry/correction requests from RIM system users globally ·         Helps establish MDM standards to enable the transfer of information from data entry request forms into the established systems ·         Ensures sustained data quality ·         Acts as the liaison to client management for all process-related items ·         Escalates issues and concerns from team members ·         Conveys feedback from the client to team members ·         Responsible for establishing and providing oversight to the data management team, ensuring that: • Team members are trained appropriately and understand their roles • Service levels are met • All deliverables are produced according to the process and within the agreed timelines ·         Assist in identifying process improvement areas ·         Participates in governance meetings with the client regularly Works with the client to develop a clear and detailed plan for reporting metrics Required Skills & Experience: ·         Experience in developing and maintaining master data management standards for regulatory systems ·         Ability to handle transactions in line with the established procedures and policies ·         Ability to handle project operations ·         Ability to protect confidential information ·         Strong capacity to work within deadlines ·         Ability to perform the assigned tasks swiftly and accurately ·         Detail oriented ·         Outstanding skills in customer service delivery ·         Demonstrated problem-solving skills ·         Proven experience in analyzing information in support of data management activities ·         Managing processes and ensuring staff compliance ·         Experience in Six Sigma methodology ·         Experience in supporting and working with tools and systems used in the Regulatory Affairs environment ·         Develo