Regulatory Information System
Description of Role and Responsibilities:This role directly contributes to the Company’s revenue growth and margin by leading operational teams in the Regulatory space. Specifically• Lead and deliver Regulatory Affairs advisory services, including Sub Management, M&A initiatives, RIM remediation, etc.• Define and build solutions for clients based on the scope of work• Work with Genpact sales to draft responses to RFPs• Build leadership connects & networks with global Regulatory leaders• Contribute to the organizations top line growth and profitability by ensuring that projects are delivered on time and within budget• Represent Genpact in governance meetings with clients and on oral presentations supporting new business• Represent Genpact at relevant conferences, tradeshows, and industry forumsPreferred Qualifications:• Bachelor's degree required in science, engineering, or related field• 10+ years’ experience in Regulatory Affairs, either Strategy, Information Management or Operations• A deep understanding of Life Sciences eco-system and the current market dynamics• Domain knowledge of regulatory requirements in a given region; multiple regions a plus• Prior experience running large scale RA projects within the industry• Proven project management skills• Robust communication and presentation skillsDesired Experience:• Experience in Regulatory Strategy and/or Operations• Experience leading the execution of submissions for top pharma companies• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines• Experience leading programs across multiple projects and clientsThis position requires a self-motivated and organized individual with the ability to exercise flexibility, decision-making maturity, with problem solving and listening skills. Internal drive, work ethic, and leadership skills. Excellent communication and executive presence to connect at the C level. Viewed as insightful, creative, articulate, persuasive, and organized.Additionalo Provides global leadership and accountability for RIM systems, operations, and data across R&D.o Acts as single point of ownership for system performance, data quality, compliance, and inspection readiness.o Defines and drives the RIM systems strategy, roadmap, and operating model aligned to enterprise objectives.o Serves as functional lead and business process owner, representing RIM internally and externally as required.o Leads business driven system transformation, translating regulatory needs into scalable digital solutions.o Provides senior people leadership across system owners, business analysts, and project managers.o Ensures strong governance, risk management, and operational excellence across global environments.
