Regulatory Affairs Pharmacist

RESPONSIBILITIES:

• Handle the registration and renewal of assigned products and licenses to FDA
• Collate and evaluate registration documents from the principal
• Check the quality of promotional materials such as brochures, product leaflets if in accordance with the regulation of FDA
• Prepare and edit labeling materials for FDA submission
• Follow-up and monitor the status of product and LTO registration applications to FDA
• Check the quality of Returned Upon Delivery vaccines/biological before it can be transferred to trade stocks
• Quality audit of assigned principals
• Keep retention samples of each batch of assigned products
• Maintain database like FDA applications and certificates
• Provide an update to principals and multiple departments regarding the status of registrations, new developments such as policies and regulations
• Assist in the conduct of Clinical Trials
• Create or implement regulatory affairs rules and procedures

REQUIREMENTS:

• Graduate of Bachelor’s Degree in Pharmacy; Must be a Registered Pharmacist
• With at least 2 years related experience in Regulatory
• Familiarity with FDA processes, policies ad regulations
• Strong regulatory knowledge in product registration and licensing
• Must be detail-oriented and organized
• Good communication skills