Key Responsibilities:
Product Registration:
- Handle product registration for dietary supplements and medical devices in accordance with legal requirements.
- Coordinate and closely collaborate with the FDA, partners, production, and quality control teams to prepare accurate registration documents within specified timelines.
Documentation:
- Prepare documents for drug registration renewals and related licenses.
- Submit, amend, and update product registrations as assigned.
- Plan and track the status of submitted registration documents, and organize them for easy access and retrieval.
Regulatory Compliance:
- Ensure licenses and registrations for drugs and medical devices comply with current regulations and are efficiently implemented.
- Submit product samples for quality testing and verify product labels against FDA requirements before production.
Coordination:
- Liaise with government officials and agencies.
- Report registration status and communicate relevant legal updates from the FDA to all concerned parties.
Qualifications:
- Bachelor's degree in Pharmacy (with a professional license in pharmacy)
- Experience in the registration of modern pharmaceuticals.
- Experience in handling drug registration responsibilities.
- Intermediate or higher proficiency in English.
- Strong proficiency in computer programs such as MS Office and other standard software used with FDA systems and related agencies.
- Knowledge and understanding of drug registration guidelines and regulations.
- Ability to work and communicate effectively with colleagues across all departments and maintain a positive and open attitude.
