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Job Description
Job Requirements
Education and Experience:
- Medical background degree or equivalent professional qualification
- At least 5-6 years relevant experience within the regulatory affairs discipline
- CTD and Export Experience is preferable
- Knowledge of Medical Device and NFSA Regulatory requirements
- Relevant product and industry knowledge is preferable
- Pesticides and disinfectant Regulatory requirements
Key Competencies:
- Excellent written and verbal communication skills organization and planning
- Problem analysis and problem-solving
Job Requirements
About the Job
Main Job Tasks and Responsibilities:
- Acting as front office for all documents submitted to CAPA or NODCAR.
- 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
- Responsible for all steps of Research issues.
- Responsible for getting Release permeation for any Shipment from CAPA.
