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 companys 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 Masters 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.
