10 - 20 years
15 - 30 Lacs
Posted:1 week ago|
Platform:
Work from Office
Full Time
Role & responsibilities Must be capable of managing a regulatory team consisting of 10 to 15 individuals. Compile and submit regulatory documents, applications, and reports to regulatory authorities such as those in the UK, EU, and Canada. Convey regulatory requirements and guidelines to internal departments, such as research and development, manufacturing, and quality assurance. Serve as a point of contact between the organization and regulatory bodies, participating in meetings and addressing inquiries. Formulate and execute regulatory approaches for product development, approval, and post-market monitoring. Gather, evaluate, and oversee data related to regulations, encompassing clinical trial information and post-market monitoring data. Perform risk evaluations concerning regulatory compliance and create strategies for mitigation. Review and approve regulatory-related documentation, including labeling, marketing materials, and user manuals.
Kopran
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