#ACN-GN I&E life Science R&D Regulatory
Job Title
Management Consultant
Management Level
9, 11
Location
Gurugram, Hyderabad, Bengaluru, Mumbai, Chennai, Pune
Skill Area
Regulatory Affairs, Veeva Vault RIM
Experience
Minimum 3–5 years in Regulatory Affairs / Regulatory Information Management
About the Role
You will be aligned with our Life Sciences R&D vertical, under the Regulatory Affairs consulting practice. Our Regulatory practice partners with leading global biopharmaceutical companies to modernize Regulatory operating models, transform Regulatory Information Management (RIM) capabilities, and enable compliant, data-driven regulatory processes through digital transformation.
As a Regulatory Consultant/Analyst, you will lead and support end-to-end Regulatory transformation engagements spanning business process consulting, regulatory operating model design, platform assessments, Veeva Vault RIM implementations, data transformation, testing, change management, and regulatory compliance initiatives
Key Responsibilities
In this practice, you'll help drive transformation across global Life Sciences organizations through the following initiatives:
- Support the delivery of consulting engagements for global Life Sciences clients across Regulatory and broader R&D functions.
- Drive strategy design, operating model transformation, business process redesign, business analysis, implementation, program management, and change management initiatives.
- Partner with global account team to identify, shape, and pursue new business opportunities.
- Provide functional and industry expertise across Regulatory Affairs and adjacent R&D domains to solve complex business challenges.
- Develop consulting assets, methodologies, thought leadership, research, whitepapers, and points of view to strengthen practice capabilities.
- Support operating model assessments, process transformation initiatives, implementation readiness assessments, and transformation roadmap development.
- Contribute to proposals, solutioning, and business development activities in collaboration with cross-functional teams.
- Lead or support business analysis activities, including workshop facilitation, requirements gathering, process mapping, user story development, backlog management, testing, and solution validation.
- Identify opportunities to leverage AI and Generative AI across Regulatory processes, operating models, and digital transformation initiatives.
- Build reusable assets, accelerators, and best practices to enhance project delivery and capability development.
- Continuously build consulting, industry, functional, and technology capabilities to support evolving client needs.
Good-to-Have / Preferred Skills
- Experience with Veeva Vault RIM applications including, Submissions, Submission Archive, Registration, and Submission Publishing, among others
- Knowledge of IDMP/SPOR, Commitment Management, and Regulatory master data management
- Familiarity with Regulatory platform selection, RFP processes, and technology assessment/scorecard development
- Exposure to Regulatory data, GxP validation support, testing (SIT/UAT), and change management activities
- Understanding of AI/GenAI, automation, or analytics use cases for Regulatory Affairs
About Accenture
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions - underpinned by the world’s largest delivery network. Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com
Must-Have Skills & Experience
- MBA from a Tier 1 institute or equivalent relevant industry experience
- 3-5+ years of progressive business and/or consulting experience, including at least 1 year in the Life Sciences industry
- Demonstrated experience in management consulting, business and technology transformation projects and strategic advisory engagements.
- Familiarity with consulting methodologies like business process mapping, operating model design, requirements gathering, business case development, and diagnostic assessments
- Knowledge of Regulatory Affairs processes and Health Authority requirements for major markets like USA, Europe, Japan etc.
- Experience across one or more Regulatory domains, including Registrations, Submission Management, Submissions Publishing, Regulatory Intelligence or Health Authorities Interactions.
- Hands-on experience with one or more Regulatory platforms such as Veeva Vault RIM, Lorenz DocuBridge, Extedo, or equivalent
- Experience on at least 1–2 Regulatory transformation projects
- Strong functional skills: Business Analysis, Requirements Gathering, Business Process Modeling, Project & Stakeholder Management
- Excellent communication, stakeholder management, and problem-solving skills
Bengaluru
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