Regulatory Associate

Job Mission/Objective:

Processes and provides technical and physical support to the implementation of regulatory programs under the supervision of the Regulatory Manager.

Duties/Responsibilities:

• Assist in obtaining and maintaining government approval of product registration, shipping permits and other relevant product licenses.
• Responsible to liaise and coordinate with local city government offices in obtaining permits of company’s importers such as Business Permit, Barangay Clearance
• Prepare and Monitor payment requisition to ensure timely settlement of registration and related regulatory payables.
• Ensure systematic filing, completeness, confidentiality of documents and compliance to the companies’ standards and preparedness during local audits (FDA and other regulatory authorities)
• Regularly updating the summary list/ record of approved, under approval, disapproved and expired product registration.
• Provide assistance in maintenance of regulatory files, regulatory server, product database and labelling folder
• May assume auxiliary roles and responsibilities to support activities of the Regulatory Specialists
• To perform other tasks as may be assigned that are relevant to the existing work responsibility as instructed.

Qualifications:

• Bachelor's Degree in Pharmacy.
• Licensed Pharmacist with a valid PRC license.
• Fresh graduates are welcome to apply; experience in regulatory affairs is an advantage.
• Knowledge of FDA regulations, product registration, and compliance requirements is preferred.
• Proficient in Microsoft Office applications.
• Strong attention to detail, organizational, and documentation skills.
• Excellent communication and coordination skills.
• Ability to manage multiple tasks and meet deadlines.
• Willing to process permits and coordinate with government agencies as needed.