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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
Key Responsibilities
- Handle product registration, renewal, and variation applications for submission to the FDA and other relevant agencies.
- Ensure compliance with all applicable pharmaceutical and medical device regulations.
- Prepare, review, and maintain regulatory documents, licenses, and certificates.
- Coordinate with internal departments, manufacturers, and importers regarding documentation and compliance requirements.
- Monitor updates on FDA and regulatory guidelines to ensure continued adherence to current standards.
- Liaise with FDA officers and inspectors during audits and inspections.
- Provide timely responses to queries and concerns from regulatory authorities.
- Support Sales and Marketing in matters related to product registration and regulatory compliance.
- Prepare and review bidding documents, particularly for government hospital bidding.
- Maintain organized records and filing sys...