Job Location: Quezon City

Job Description:

• Prepare and submit product registration dossiers for pharmaceutical products.
• Process applications for License to Operate (LTO), Certificate of Product Registration (CPR), and other regulatory permits.
• Coordinate with the Food and Drug Administration regarding product approvals, renewals, and compliance updates.
• Monitor updates on regulatory policies, circulars, and issuances from regulatory bodies.
• Ensure product labels, packaging materials, and promotional materials comply with regulatory standards.
• Maintain regulatory documentation and database records.
• Assist in handling product variations, amendments, and post-approval changes.
• Support pharmacovigilance and adverse event reporting requirements.
• Work closely with Quality Assurance, Supply Chain, and Marketing teams to ensure regulatory compliance.
• Prepare and submit periodic reports as required by regulatory authorities.

 

Qualifications:

• Bachelor’s Degree in Pharmacy (Licensed Pharmacist).
• Registered Pharmacist with a valid PRC license.
• With at least 1–3 years of experience in regulatory affairs (preferred).
• Strong knowledge of pharmaceutical regulations and FDA requirements.
• Excellent attention to detail and organizational skills.
• Good communication and coordination skills.
• Proficient in documentation and regulatory submission processes.