Regulatory Affairs Pharmacist
Makati Full-time
Key Responsibilities
- Ensure products comply with local and international regulations.
- Keep updated with changing laws and regulatory requirements.
- Prepare and submit dossiers for product approval.
- Compile regulatory documents.
- Ensure accuracy and completeness of technical data.
- Review product labels, inserts, and packaging to ensure regulatory compliance.
- Advise companies on approval pathways and timelines.
- Support product lifecycle management (variations, renewals).
- Bachelor’s degree in Pharmacy (BPharm), Master’s degree in Regulatory Affairs, Pharmacy, or related field
- Licensed pharmacist.
- Knowledgeable in Regulatory guidelines (FDA, EMA, ASEAN guidelines, etc.)
- At least 3 years experience as Regulatory Pharmacist (Cosmetics and Personal Care Product).
- Handle FDA registration, renewals, and permits
- Ensure all products meet Philippine FDA regulations and standards.
- Review labels, packaging, and promotional materials for compliance
- Maintain regulatory databases and records of approvals and submissions
- Ensure accurate documentation for audits and inspections
- Support quality assurance (QA) and Good Distribution/Manufacturing Practices (GDP/GMP)
Gramans Group of CompaniesMuntinlupa, 20 km from Makati
Job Summary:
We are seeking a knowledgeable and detail-oriented Regulatory Affairs Officer to lead and oversee all regulatory processes for our product lines including pharmaceuticals, food, and cosmetic products. The ideal candidate is a licensed...
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