Regulatory Pharmacist

Key Responsibilities

• Handle product registration, renewal, and variation applications for submission to the FDA and other relevant agencies.
• Ensure compliance with all applicable pharmaceutical and medical device regulations.
• Prepare, review, and maintain regulatory documents, licenses, and certificates.
• Coordinate with internal departments, manufacturers, and importers regarding documentation and compliance requirements.
• Monitor updates on FDA and regulatory guidelines to ensure continued adherence to current standards.
• Liaise with FDA officers and inspectors during audits and inspections.
• Provide timely responses to queries and concerns from regulatory authorities.
• Support Sales and Marketing in matters related to product registration and regulatory compliance.
• Prepare and review bidding documents, particularly for government hospital bidding.
• Maintain organized records and filing systems for regulatory documents.
• Perform other related tasks as may be assigned from time to time.

Qualifications

• Licensed Pharmacist (with valid PRC license).
• Preferably with 1–2 years of experience in regulatory affairs or FDA registration of medical supplies.
• Knowledgeable in regulatory documentation, product registration, compliance processes, and government hospital bidding.
• Computer literate and highly organized, with strong analytical and problem-solving skills.
• Excellent communication, coordination, and leadership abilities.
• Proactive, detail-oriented, and capable of handling multiple tasks efficiently.
• Willing to be assigned in Greenhills, San Juan City, Metro Manila.