Regulatory Pharmacist

Raya Clinic; Makati; On-site; PHP 334,800 - 558,000; Full time

Job summary

A healthcare provider in Metro Manila seeks a Regulatory Pharmacist responsible for ensuring compliance with Philippine FDA regulations. You will handle applications for product registration, maintain licenses, and provide regulatory guidance across teams. Candidates must be licensed pharmacists with a Bachelor's in Pharmacy and have experience in regulatory affairs. Strong communication and analytical skills are essential for this role.

Qualifications

• Licensed Pharmacist in the Philippines.
• Bachelor of Science in Pharmacy graduate (Doctor of Pharmacy or Master’s is a plus).
• Experience in regulatory affairs or compliance.

Responsibilities

• Prepare, review, and submit applications for product registration.
• Secure and maintain company licenses and permits.
• Ensure compliance with regulatory requirements.

Skills

Regulatory compliance

Attention to detail

Analytical skills

Communication skills

Organizational skills

Education

Licensed Pharmacist in the Philippines

Bachelor of Science in Pharmacy

Job description

The Regulatory Pharmacist will be responsible for ensuring compliance with Philippine FDA regulations and other applicable laws governing the registration, licensing, distribution, and marketing of pharmaceutical products. The role involves preparing and submitting regulatory dossiers, securing necessary permits, and monitoring regulatory changes to support the company’s operations and product portfolio.

• Prepare, review, and submit applications for product registration, renewals, and post-approval variations to the Food and Drug Administration (FDA) and other relevant agencies.
• Secure and maintain company licenses (LTO, CPR, FDA notifications, etc.).
• Ensure that all pharmaceutical products and company operations comply with current regulatory requirements.
• Provide regulatory guidance to management and other teams, including R&D, quality assurance, and marketing.
• Support audits, inspections, and compliance reviews.
• Maintain Good Regulatory Practice and uphold ethical standards of the profession.

Qualifications:

• Licensed Pharmacist in the Philippines.
• Bachelor of Science in Pharmacy graduate (Doctor of Pharmacy or Master’s degree is a plus).
• Must have experience in regulatory affairs, compliance, or pharmaceutical operations.
• Knowledge of current FDA e-portal systems and regulatory processes.
• Strong attention to detail, analytical, and documentation skills.
• Excellent communication and organizational skills.
• Ability to work independently and collaboratively across teams.