Regulatory Affairs Officer

Qualifications:

• Bachelor's degree in Pharmacy or a related field.
• Licensed pharmacist is an advantage.
• With at least 2 - 3 years of experience working in a manufacturing setting such as pharmaceuticals and cosmetics as a Regulatory Affairs Officer.
• With knowledge in GMP, FDA Philippines rules, ISO, and audit process and manufacturing compliance standards.
• With excellent documentation and attention to detail abilities.
• Outstanding coordination and communication abilities.

Responsibilities

• Prepare, submit, and maintain regulatory licenses, permits, and product registrations (e.g., FDA LTO, CPR, renewals).
• Coordinate with regulatory agencies (FDA Philippines, DOH, DTI, DENR, LGUs) and support inspections and audits.
• Monitor regulatory updates and assess their impact on manufacturing processes and products.
• Collaborate with cross-functional teams and maintain accurate regulatory...