Greetings from Talisman HR Solutions!We are hiring RA Specialist for MNC Pharmaceutical company at BKC Mumbai
Designation: RA Specialist
Experience: 3+ Years
Salary: Best in industry
Working days: Mon to Fri
Working time: 09:30 am to 06:00 pm
Location: BKC, Mumbai
Payroll Company: Talisman HR Solution
Note: This role will be on Third party payrollJOB SUMMARYResponsible 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 IndiaCORE JOB RESPONSIBILITIES
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.
Minimum Education
Bachelor in Pharmacy (B. Pharma).
Graduate/Post Graduate (Biochemistry, Biotechnology, Microbiology, Immunology, Medical technology, pharmacy, Pharmacology) is preferred.
Masters in above field will be preferred
Interested candidates share resume on talent@talismanstaffing.com