• Prepare, review, and submit product registration dossiers to the FDA (Food and Drug Administration) and other relevant regulatory bodies.
• Ensure all products comply with local laws and regulations, including labeling, advertising, and marketing guidelines.
• Maintain up-to-date knowledge of current local and international regulatory requirements.
• Act as the primary liaison with regulatory agencies and respond to queries or audits as needed.
• Monitor and manage product renewals, amendments, and post-approval variations.
• Support quality assurance and pharmacovigilance functions, as needed.

• Licensed Pharmacist in the Philippines
• At least 1 year of experience in regulatory affairs or a related pharmaceutical role
• In-depth knowledge of FDA regulations, product registration processes, and other applicable laws
• Excellent communication, documentation, and organizational skills
• Strong attention to detail and the ability to manage multiple deadlines

Preferred Qualifications:

• Experience with regulatory affairs in pharmaceuticals, and medical devices
• Familiarity with ASEAN CTD/ICH guidelines
• Background in quality assurance or product development is a plus