
Regulatory Pharmacist
4 days ago
Job description
Key Responsibilities:
- Prepare, review, and submit product registration dossiers to the FDA (Food and Drug Administration) and other relevant regulatory bodies.
- Ensure all products comply with local laws and regulations, including labeling, advertising, and marketing guidelines.
- Maintain up-to-date knowledge of current local and international regulatory requirements.
- Act as the primary liaison with regulatory agencies and respond to queries or audits as needed.
- Monitor and manage product renewals, amendments, and post-approval variations.
- Support quality assurance and pharmacovigilance functions, as needed.
Qualifications:
- Licensed Pharmacist in the Philippines
- At least 1 year of experience in regulatory affairs or a related pharmaceutical role
- In-depth knowledge of FDA regulations, product registration processes, and other applicable laws
- Excellent communication, documentation, and organizational skills
- Strong attention to detail and the ability to manage multiple deadlines
Preferred Qualifications:
- Experience with regulatory affairs in pharmaceuticals, and medical devices
- Familiarity with ASEAN CTD/ICH guidelines
- Background in quality assurance or product development is a plus
Job Type: Full-time
Pay: Php25, Php30,000.00 per month
Work Location: In person
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