Regulatory System Associate
Location: Hyderabad, Andhra Pradesh, India
Employment Type: Full-time
Job Requisition ID: 521294
Role Purpose:
The Regulatory System Associate will manage the Regulatory Information Management (RIM) system for all Consumer Healthcare products worldwide. This role supports key regulatory processes to meet regulatory, legal, and pharmacovigilance obligations, including preparing and storing regulatory submissions, labeling, planning/tracking, and generating KPIs/metrics and compliance reports. The Associate will collaborate closely with central, regional, and local regulatory CH teams, as well as key external regulatory agencies/trade associations, ensuring compliance and efficient data management.
Key Responsibilities:
- System and Process Enhancements: Identify and drive changes to enhance data quality, user experience, and compliance.
- Guidance and Support: Provide guidance for system upgrades and enhancements supporting regulatory processes and obligations.
- System Performance Monitoring: Ensure system performance issues are resolved effectively.
- Collaboration with IT: Partner with IT on system implementation and change control activities, including iQMS IT quality documentation, test scripts, and reports.
- System Reports: Manage the design, validation, and delivery of regulatory compliance reports and department KPIs, ensuring timely delivery.
- Data Compliance: Ensure high-quality data capture, identify and address data errors, and drive data remediation initiatives.
- User Training and Support: Deliver effective system user training, manage system access, and support users day-to-day.
- Stakeholder Communication: Champion registration tracking through regular communication with global stakeholders.
- Additional Support: Assist with other systems team activities as necessary.
Qualifications:
- Education: Bachelor’s degree or equivalent experience.
- Experience: At least 2 years in regulatory operations or a similar role within the pharmaceutical industry, specifically in Regulatory Affairs.
- Regulatory Knowledge: Understanding of global regulatory affairs processes and familiarity with non-prescription healthcare products, including OTC medicines, cosmetics, and devices.
- Regulatory Systems: Awareness/experience of EMA EudraVigilance and Medicinal Product Dictionary (EVMPD) requirements. Advanced knowledge of Regulatory Information Management.
- Technical Skills: Proficient with database applications, concepts, and reporting. Advanced use of Microsoft Excel. Knowledge of Insight Manager application and cloud-based applications.
- Project Management: Experience in project and business analysis, systems validation, and quality methodologies (e.g., iQMS, Agile).
- Organizational Skills: Excellent organizational and coordination skills.
- Editorial Skills: Clear and accurate editorial skills for consistent and meaningful data reporting.