Assistant Regulatory Officer - Pharma

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 strategy
• Timely compile materials for license renewals, updates and registrations
• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Review labeling and labels for compliance with regulatory requirements
• Review changes to existing products and SOPs to define the requirements for regulatory submissions
• Provide the regulatory reviews of customer complaints and define the regulatory re-portability
• Responsible for timely registration of the facility
• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
• Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes
• Participate 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.