PHARMACIST

We are looking for a Pharmacist who will oversee FDA regulatory requirements and ensure the company’s pharmaceutical products and operations remain compliant with applicable laws, regulations, and standards. The role involves regulatory documentation, product registration, compliance monitoring, and coordination with the FDA and other relevant regulatory agencies.

Responsibilities

• Ensure compliance with FDA regulations, guidelines, and requirements for pharmaceutical products and operations.
• Prepare, review, and maintain documents required for product registration, licensing, and regulatory submissions.
• Monitor the status of FDA applications, registrations, permits, and licenses, ensuring timely renewals.
• Coordinate with the FDA and other regulatory agencies regarding submissions, inquiries, inspections, and compliance matters.
• Review product labels, packaging, promotional materials, and other documents for regulatory compliance.
• Maintain accurate and updated regulatory records and documentation.
• Monitor changes in FDA regulations and communicate relevant updates to management and concerned departments.
• Conduct compliance checks and assist in addressing regulatory findings or deficiencies.
• Support the implementation of corrective and preventive actions related to regulatory concerns.
• Ensure products and business activities comply with applicable Good Manufacturing, Distribution, and Pharmacy Practices, as relevant.
• Assist in preparing for regulatory inspections and audits.
• Perform other regulatory and compliance-related duties as assigned.

Qualifications

• Licensed Pharmacist (RPh) with a valid PRC license.
• Bachelor’s degree in Pharmacy or related field.
• Preferably with experience in FDA regulatory affairs, pharmaceutical compliance, or product registration.
• Knowledge of Philippine FDA regulations, guidelines, and regulatory processes.
• Familiarity with product registration, LTO, CPR, and other regulatory requirements is an advantage.
• Strong attention to detail and excellent documentation skills.
• Good communication and coordination skills.
• Ability to monitor regulatory deadlines and manage multiple submissions.
• Proficient in Microsoft Office applications.
• Organized, analytical, and able to work independently.