Assistant Regulatory Officer

2 days ago


Vadodara, Gujarat, India Actide International Full time ₹ 5,00,000 - ₹ 7,50,000 per year


Job Description:

Duties and Responsibilities :

Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategyTimely compile materials for license renewals, updates and registrationsMaintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partnersReview labeling and labels for compliance with regulatory requirementsReview changes to existing products and SOPs to define the requirements for regulatory submissionsProvide the regulatory reviews of customer complaints and define the regulatory re-portabilityResponsible for timely registration of the facilityMaintain current knowledge of FDA and international regulation, guidance and standards applicable to company productsActively participate in evaluation of regulatory compliance of document / product /process /test methods changesParticipate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.Salary shall be commensurate to experience and qualification.


Working location shall be around 20 Km from Vadodara and company transport will be available.




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