Manager – Regulatory Affairs – CRLB Division
About the job
- Responsible for all registration activities including submissions into SUGUM Registration System for Medical Devices and Diagnostics for India Market only
- Provide support to India business managers for regulatory related issues in India
- Provide strategy to management for rapid product approval and timely market entry into India
Core Job Responsibilties
- Compile and review regulatory submissions for timely registration of new products & renewal of entire range of on-market products for India
- Ensure product regulatory launch plan is strictly met
- Provide inputs on possible factors which may impact the regulatory launch plan timeline of new product line for ADD
- Provide timely inputs when there is a need to modify product launch timeline with adequate time to implement same without any financial/resource constraints
- Identify upcoming/evolving regulatory requirements for new IVD product launch
- Serve as ADD RA representative in industry/regulatory meetings
- To maintain good contact and ensure timely follow-up with Indian regulatory agencies
- Determine the scope of information/documentation necessary to file new registration applications and post-approval changes according to existing checklists to regulatory agencies
- Review product labelling material for compliance with applicable regulations and standards
- Ensure regulatory project deadlines and performance standards are established and met
- Ensure timely submission of products at NIB for performance evaluation of products for the purpose of registration
- Draft processes for new regulatory requirements towards effective implementation
- Coordination for Local testing for the purpose of generation of performance evaluation reports from Central Medical Testing Laboratory. Ensure receipt of IVD kits for submission to National Institute of Biologicals, Noida, follow up of reports and communication of related issues to Abbott and coordinate with NIB for newer plans of testing and improving future business relations with NIB etc. Ensure receipt of Invoices against payment done
Experience Details
Minimum of 6-8 Years
Regulatory Experience. Association or working experience in Central/State regulatory authority will be preferred.