Posted:22 hours ago|
Platform:
Work from Office
Full Time
Life Sciences Regulatory Affairs Associate - RIM plays a crucial role in ensuring compliance within the pharmaceutical, medical devices and biotechnology industries by managing the assigned regulatory affairs RIM activities for regulatory submissions, health authority queries, approvals, variations, renewals/ licence maintenance & regulatory compliance throughout the product lifecycle. This role involves preparing and reviewing regulatory information, maintaining compliance with global standards and regulations, and utilizing Regulatory systems to track and organize critical data for various assigned activities.
9. Compliance and Standards: Ensuring adherence to global regulatory guidelines such as ICH, ICH-GCP, GMP and managing product registration and maintenance across different markets.
10. Cross-functional Collaboration: Working with various client teams (e.g., RA, QA etc.) to ensure timely and accurate regulatory information and ongoing compliance. Monitor regulatory changes and ensure RIM system compliance. Support audits and inspections by Notified Bodies and regulatory agencies by maintaining accurate records and submission history.
11. Data Management and Reporting: Maintaining accurate records of all regulatory activities and leveraging Document Management, Publishing and RIM tools to extract insights and support decision-making.
Regulatory Affairs, RIM systems,UAT, Data Management, Metadata,Testing and Documentations
UST
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