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.