Information Systems Compliance Specialist

15 hours ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 7,00,000 - ₹ 12,00,000
Regulatory IT Specialist Job Overview

The Regulatory IT Specialist will play a pivotal role in the development, implementation, and maintenance of structured regulatory submission solutions. This position requires strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. The ideal candidate will work closely with cross-functional teams to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements.

Responsibilities
  • Implement and manage regulatory submission systems, ensuring alignment with global and regional regulatory requirements (e.g., eCTD, NeeS)
  • Collaborate with stakeholders to gather business requirements and translate them into technical solutions
  • Assist in defining and executing project plans, timelines, and resource allocation from system assessment through to deployment and post-production support
  • Contribute to validation planning and execution, including IQ/OQ/PQ protocols, aligned with GxP and 21 CFR Part 11
  • Support structured document authoring workflows and content lifecycle management in integration with systems like Veeva RIM
  • Oversee system configurations such as user access controls, audit trails, and role-based security
  • Manage system change control aligned with ITIL practices to ensure compliance and traceability
  • Develop training content and conduct end-user training for regulatory users and business stakeholders
  • Monitor system performance, address issues in collaboration with vendors and business teams, and ensure minimal disruption
  • Drive continuous improvement to enhance system usability, performance, and compliance
  • Track KPIs and provide leadership with system performance, adoption, and risk updates
  • Contribute to strategic roadmap planning for enhancements, upgrades, and integrations (e.g., API tools)
  • Represent the team as a subject matter expert during audits, inspections, and regulatory reviews
Requirements
  • Master's degree or Bachelor's degree with 5 to 9 years of relevant experience
  • Strong understanding of pharma regulatory compliance (FDA, EUCTR)
  • Hands-on experience with Veeva RIM and Lorenz DocuBridge
  • Demonstrated experience in managing IT initiatives and collaborating across teams
  • Ability to manage multiple priorities with minimal supervision in a dynamic environment
  • Knowledge of IT methodologies including Scaled Agile (SAFe) and ITIL
  • Excellent communication and collaboration skills
  • Strong understanding of information systems and network technology fundamentals
Benefits
  • Opportunity to work on cutting-edge projects and technologies
  • Professional growth and development opportunities
  • Collaborative and dynamic work environment

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