Regulatory Affairs Executive
2 weeks ago
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.
**Salary**: ₹25,000.00 - ₹35,000.00 per month
**Benefits**:
- Provident Fund
Schedule:
- Day shift
Ability to commute/relocate:
- Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (required)
Application Question(s):
- bachelor of pharmacy is completed or not?
**Education**:
- Bachelor's (required)
**Experience**:
- total work: 3 years (required)
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