31/01/2022
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 or B.S Pharmacy graduate
-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