JD:-

Key Responsibilities :-

1. Digital Transformation & RegTech Innovation

• Platform Modernization: Oversee the strategic architecture and transition of legacy regulatory tracking tools (e.g., SharePoint) into up-to-date, cloud-governed, multi-model database platforms (e.g., AWS, MarkLogic, Veeva RIM).

• AI & Automation Enablement: Drive shift from manual monitoring to AI-powered proactive alert systems, web-scraping/scraping automation, and natural language processing (NLP) for rapid policy impact analysis.

• eCTD & RIM Workflow Optimization: Streamline submission workflows and integrate intelligence feeds directly into electronic Common Technical Document (eCTD) publishing and Regulatory Information Management (RIM) systems.

2.Practice Leadership & Growth

• Business Development: Lead engagement proposals (RFPs/RFIs), deal shaping, technical solutioning, and statement of work (SOW) development for regulatory consulting opportunities.

• Thought Leadership: Develop industry white papers, point-of-view assets, and target operating models (TOM) on emerging regulatory trends, digital compliance, and cloud governance.

• Team & Stakeholder Management: Lead cross-functional consulting teams, mentor junior consultants, and manage senior-level client relationships across Regulatory, IT, Quality, and Legal.

3. Client Engagement & Strategic Advisory

• Regulatory Surveillance & Strategy:



Lead the strategy and delivery of enterprise Regulatory Intelligence (RegIntel) programs, helping clients systematically monitor, triage, and operationalize changing global health authority requirements (FDA, EMA, PMDA, MHRA).

• Gap Analysis & Risk Management: Direct end-to-end impact assessments, regulatory gap analyses, and Risk Monitoring Frameworks across R&D;, Clinical, Pharmacovigilance, and Regulatory Affairs.

• Inspection Readiness & Mock Audits: Spearhead compliance preparation and mock health authority inspections (e.g., GxP, PVEK, pre-approval inspections) to identify documentation and process gaps ahead of formal agency audits.

Qualifications & Requirements

• Experience: 10–15+ years of experience in management consulting or industry advisory within the Life Sciences R&D; domain (Regulatory Affairs, Regulatory Operations, or Quality/Compliance).

• Domain Expertise: Deep knowledge of global regulatory frameworks, submission formats (eCTD, IDMP), regulatory intelligence lifecycles, and health authority inspection methodologies.

• Tech-Enabled Regulatory Experience: Demonstrated success in leading digital regulatory transformations, cloud-governed transitions (AWS/Azure), and database/automation platform deployments (e.g., MarkLogic, AI tracking engines).

• Leadership: Proven ability to manage complex multi-stream projects, lead high-performing teams, and drive business growth within a consulting ecosystem.

📌 LS_AZ | PM (India)
🏢 Cognizant
📍 India