Specialist - Regulatory Affairs - Operations 4B

Overview

Specialist - Regulatory Affairs - Operations responsible for maintaining regulatory data and supporting regulatory submissions, compliance, reporting, and system user support.

What you'll do

• Maintain and update regulatory data in company databases and RIMS.
• Ensure regulatory data accuracy, completeness, consistency, and compliance.
• Support preparation and tracking of submissions, approvals, renewals, variations, and registrations.
• Perform data quality reviews and reconciliation across multiple systems.
• Develop and maintain regulatory data standards, workflows, and documentation.
• Generate regulatory reports, metrics, and dashboards for stakeholders.
• Support inspections, audits, and regulatory compliance activities.

What you'll need

• Bachelor’s degree in Health Administration, Healthcare, or Pharmacy.
• Or Master’s degree in Public Health or Regulatory Affairs.
• Veeva language is required.
• English proficiency: Proficient (C2).
• Certified Compliance Officer (CCO) (Vskills) OR Certified Public Accountant (CPA) (Perfekt Szolnok) OR Certified Regulatory and Compliance Professional (CRCP) (JSS University) OR Certified Regulatory Compliance Manager (CRCM) (IARCP).

Details

• Location: 7th fl, Raiaskaran Tech Park, Sakinaka, Mumbai, India.
• Work mode: Hybrid.
• Employment type: Regular.