JOB REQUIREMENTS At least 1-year work-related experience in regulatory field handling pharmaceutical products.- Experience in handling food/food supplements, cosmetics and medical devices is an advantage.
Must have good communications skills (both oral and written) and able to work with very minimal supervision.
- Can work harmoniously with a team.
Handles registration (review and submission) and monitoring of drugs and cosmetics.
- Represents the company as Liaison Officer to the local FDA for the assigned product.
Assists in complying with the local FDA's regulatory guidelines.- Provide regulatory information through preparation of registration updates, maintenance and update of product information, registration dossiers and regulatory files; submission of updated prescribing information and other variations in technical information to FDA and includes monitoring of implementation.
Provide technical support to internal and external customer including but not limited to: prompt preparation and compilation of additional regulatory requirements in support of marketing thrusts and directions, and accomplishing regulatory reports for submission to RA Manager.
- Performs other job-related duties and responsibilities as determined by RA Manager and / or job-related tasks as needed by the company.
Job Type: Full-time
Benefits:
Health insurance
Schedule: Day shift
