Kob description:

Regulatory Pharmacist – Qualifications

Education & Licensure

• Bachelor's Degree in Pharmacy.
• With or without Pharmacy license

Experience

• With related experience as Regulatory pharmacist is an advantage but fresh graduate / newly licensed professional are encourage to apply

Knowledge & Skills

• Strong knowledge of Philippine FDA regulations, GMP, and applicable pharmaceutical laws.
• Familiarity with product registration, labeling requirements, and regulatory documentation.
• Excellent documentation, analytical, organizational, and communication skills.
• Proficient in Microsoft Office applications.
• Detail-oriented and able to manage multiple regulatory deadlines.

Job Type: Full-time

Responsibilities

-Prepare, compile, review, and maintain regulatory documents and submissions for pharmaceutical and health-related products in compliance with applicable FDA Philippines requirements and regulations.

-Assist in the preparation and filing of product registration, renewal, variation, and other regulatory applications with the Food and Drug Administration (FDA).

-Monitor the status of regulatory applications and coordinate with the FDA and other relevant regulatory agencies regarding submissions, deficiencies, clarifications, and approvals.

-Review product labels, packaging materials, product information, claims, promotional materials, and other technical documents to ensure compliance with regulatory requirements.

-Ensure that product dossiers and supporting documents are complete, accurate, updated, and properly maintained.

-Conduct regulatory research and monitor changes in FDA regulations, guidelines, circulars, and other applicable requirements that may affect the company's products and operations.

-Coordinate with Quality Assurance, Quality Control, Research and Development, Production, Marketing, and other concerned departments regarding regulatory requirements and product documentation.