Regulatory Intelligence and Operational Excellence Lead

Overview

Own the regulatory intelligence and knowledge-sharing framework for Global Drug Regulatory Affairs (GDRA), linking global, regional and Local RA teams, and drive operational excellence across GDRA processes in this newly created role.

What you'll do

• Own the regulatory intelligence and knowledge-sharing framework for Global Drug Regulatory Affairs (GDRA), linking global, regional and Local RA teams
• Monitor health authority guidance, ICH guidelines, inspection trends and competitor approvals (FDA, EMA, PMDA, Health Canada and others) relevant to CC Products, PD Solutions and Renal Pharma
• Prepare intelligence briefs and reports that turn external and internal information into clear, actionable insights for GDRA leadership and stakeholders
• Capture internal learnings from health authority interactions, approvals, labeling and inspections in a searchable knowledge base
• Enable two-way intelligence exchange with Local RA and regional teams; define when learnings warrant broader communication
• Own the intelligence process (intake, assessment, dissemination, feedback) with standard templates and reporting cadences
• Coordinate GDRA SOP harmonization and lifecycle with process owners: review schedules, version control, change communication, training
• Map and improve cross-functional regulatory workflows; use inspection observations and feedback to support root-cause assessment
• Design, coordinate and improve GDRA onboarding programs, checklists and completion tracking
• Coordinate LDRA process activities and develop training with local and global regulatory colleagues
• Administer POA review cycles and action tracking; escalate overdue items
• Maintain dashboards for SOPs, onboarding, LDRA training, POA actions and improvements; report progress and risks to the Head of Renal Pharma, Operational Excellence and Regulatory Intelligence
• Partner with RA Operations to integrate intelligence into RIMS and GDRA platforms; support due diligence and manage external sources (e.g., Citeline, RAPS)

What you'll need

• Bachelor's degree or higher in Pharmacy, Life Sciences, Chemistry, Biochemistry, or a related scientific discipline
• 12–18 years of experience in regulatory affairs, regulatory intelligence, or a closely related function in the pharmaceutical or biotechnology industry
• Demonstrated experience monitoring and synthesizing global regulatory agency guidance (FDA, EMA, ICH and others), with strong scientific literacy to interpret complex regulatory documents and dossier requirements
• Experience with SOP governance, onboarding or training coordination, POA tracking, or continuous improvement
• Proficiency in building and maintaining SharePoint, Teams, RIMS, or similar regulatory knowledge-management platforms
• Excellent written and verbal communication skills, with confidence presenting to senior regulatory leaders and distilling complex information for varied audiences
• Experience working in a global matrix across time zones; builds trust across functions and geographies without direct authority
• Analytical rigor and strategic thinking, with ownership and self-direction to set structure and cadence in a newly created role
• High proficiency in English (written and spoken), the primary working language of GDRA

Nice to have

• Experience in a GBS or shared services environment
• Exposure to NDA, MAA or equivalent submissions
• Background in CMC, labeling or nonclinical

Details

• Location: Bengaluru, Karnataka, India (Hebbal, Bangalore office)
• Hybrid work set-up