Genpact
Genpact is transforming the way businesses work with intelligent AI agents. The company specializes in providing comprehensive AI solutions and utilizes data analytics to enhance operational efficiency across various sectors including finance, supply chain management, and risk compliance. With a strong focus on digital transformation, Genpact empowers organizations to improve outcomes through innovative technology and analytics-driven decision-making.
Banking & Financial Services • Energy • Insurance • Healthcare Payer • Capital Market
Senior Manager, Regulatory Affairs - Remote UK
January 8
Genpact
Genpact is transforming the way businesses work with intelligent AI agents. The company specializes in providing comprehensive AI solutions and utilizes data analytics to enhance operational efficiency across various sectors including finance, supply chain management, and risk compliance. With a strong focus on digital transformation, Genpact empowers organizations to improve outcomes through innovative technology and analytics-driven decision-making.
Banking & Financial Services • Energy • Insurance • Healthcare Payer • Capital Market
📋 Description
• Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs • Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing) • Lead configuration requirements workshops, design, prototype, configure and document content solutions • Program and project management including resource planning, leading, and motivating a cross-functional team • Primary customer liaison managing communication between the project team, customer, and internal stakeholders • Mentor project team and consultants, helping others improve their consulting skills • Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction • Influential; experience leading teams through hard decisions and negotiating compromises • Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution • Expert on life sciences compliance and computer systems validation requirements • Ability to work independently in a dynamic environment
🎯 Requirements
• Bachelor's degree required in science, engineering or related field (advanced degree preferred) • Direct experience with systems such as Veeva Vault, PAREXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc. • Consulting experience, working with a major system integrator or software vendor • Regulatory Affairs, Regulatory Operations, or Pharmacovigilance background • Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content • PMP certification • Execution experience with Agile methodology and/or ACP Certification • Life Science, computer science or related degree • SaaS/Cloud experience • Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL) • English Fluency
🏖️ Benefits
• Attractive salary; • Stable job offers - employment contract • Work in a multicultural and diverse environment with employees from over 30 countries • Genpact supports professional tranings and great career development opportunities • Free access to our award-winning learning platform • Benefits such as Meal Tickets, Medical Services, Insurance, additional vacation days or partner discounts
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