Senior Principal Consultant, Regulatory Strategy and Advisory

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September 2

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Infosys

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Enterprise • Consulting • Artificial Intelligence

Infosys is a global leader in next-generation digital services and consulting, providing a wide range of solutions to enterprises across various industries. With expertise in AI, cloud computing, application development, and business process management, Infosys drives digital transformation for its clients, helping them navigate their digital journey with innovative offerings. The company collaborates with numerous partners to enhance business operations and has a significant presence in over 56 countries. It also focuses on developing new-age solutions in areas like blockchain, IoT, and generative AI to deliver value to businesses worldwide.

10,000+ employees

Founded 1981

🏢 Enterprise

🤖 Artificial Intelligence

💰 $200M Post-IPO Equity on 2008-07

📋 Description

• Help clients navigate transformational change in regulatory strategy and advisory • Drive futuristic IT solutions for Regulatory and Clinical areas and provide agency thought leadership • Work with business regulatory experts and IT experts globally to analyze, develop, and implement regulatory processes • Design product features for health authority submission management, content authoring, labeling, regulatory intelligence, and emerging standards • Formulate recommendations for business process and system configuration improvements and develop user requirements • Coordinate implementation across solution design, configuration, systems integration, data migration, validation, and training • Act as primary customer liaison managing communication between project team, customer, internal stakeholders, and vendors

🎯 Requirements

• Passion for helping clients navigate transformational change • Smart, self-driven, high-energy with top-notch communication skills and intellectual curiosity • Rare blend of industry domain, process, technical and consulting skills • Industry domain expertise in one or more areas of Life Sciences • Client relationship management, effective executive communication, and critical thinking in a consultative approach • Experience in value realization, process re-engineering, design thinking and agile delivery • In-depth knowledge of Pharma Regulatory Operations and Regulatory IT Systems • Expertise in Regulatory and Clinical areas and client-facing thought leadership • Understanding of health authority submissions, content authoring, labeling, lifecycle management of CMC, regulatory intelligence, and country-specific regulatory requirements • Ability to strategize and advise on product roadmap and work closely with clients • People management and mentoring experience • Master’s degree in Life Science, Medical or related discipline (MBA advantageous) • Minimum 12-15 years’ experience in Drug Development, Regulatory, Clinical Operations and Medical Devices • Deep understanding of RIM systems (Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, etc.) • Knowledge of regulatory IT systems landscape and implementation experience including integration and migration aspects