7 - 9 years
5 Lacs
Posted:8 hours ago|
Platform:
Work from Office
Full Time
Life Sciences Regulatory Affairs Team Leader - 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.
1. Lead and manage the RIM team to support global regulatory submissions and lifecycle management. Oversee implementation, configuration, and maintenance of RIM platforms (e.g., Veeva Vault RIM, LifeSphere RIMS, ArisGlobal Regulatory One, Master Control Regulatory Excellence, ArisGlobal, EXTEDO systems/ plateforms).
2. Ensure regulatory data accuracy, completeness, and compliance with global standards (e.g., IDMP, xEVMPD, UDI).
3. Collaborate with cross-functional teams (Regulatory Affairs, Quality, IT, Clinical) to align RIM strategies.
4. Drive continuous improvement initiatives for regulatory processes and system usability.
5. Monitor KPIs and generate reports on submission timelines, system usage, and data quality.
6. Provide training and support to users on RIM tools and workflows.
7. Stay updated on evolving regulatory requirements and digital trends (e.g., eCTD, R3, structured content authoring).
8. Manage vendor relationships and coordinate system upgrades or integrations.
9. Ensure audit readiness and support inspections related to regulatory systems and data
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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