Regulatory Affairs Coordinator

Educational Attainment:

• BS Pharmacy Graduate preferably licensed

Skills:

• At least 1 year experience
• Computer Literate
• Proficient in MS Word & Excel
• With Good Interpersonal
• Oral Communication Skills
• cGMP Oriented

Duties and Responsibilites:

• Reports directly to the RA Supervisor and assist for any regulatory concerns/ sectional activities

• Monitors and coordinates requirements needed for initial and renewal registration of Pharmaceutical, Food, Cosmetics and Household Hazardous Substance

• Evaluates technical documents received from QC and RAD prior to submission;

• Assists the Liason Officer in product registration submission at FDA, BAI and FPA

• Coordinates representative sample to RAD needed for new products and QA Existing products

• Maintains and updates product registration profile for all transactions made at regulatory bodies for a faster review and traceability

• Prepares and coordinates compliance checklist of Notice of Deficiencies/Denial received.

• Reviews validity of CPR's and necessary changes to align with regulatory guidelines

• Facilities evaluation report for discrepancies noted in technical documents for registration