
Regulatory Pharmacist
2 days ago
Duties:
- Handle initial, renewal and variation FDA registrations (LTO, Certificate of Product Registration and other FDA requirements)
- Being responsible for ensuring compliance with applicable government rules and regulation
- Determine and communicate medical devices approval requirements
- Compile and submit documents to regulatory agencies
- Participate as a member of a regulatory team
- Respond to regulatory officials and meet deadlines
- Do product research and development and apply it to the improvement of the company
Qualifications:
- Candidate can be a Licensed Pharmacist
- At least 1 - 3 Year(s) of working experience in the related field
- Able to work in a fast-paced environment
- Excellent in MS Office tools (Excel, Word, Powerpoint, etc.)
- Detail oriented, problem-solving and analytical skills, excellent organizational skills
- Ability to work independently or part of a team
- Knowledgeable in manufacturing, Quality Control, and Quality Assurance processes
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