The Regulatory Officer ensures the company's full compliance with regulatory requirements and supports ISO documentation and quality processes. This role requires a licensed pharmacist with experience in regulatory affairs and ISO standards.
Key Responsibilities:
- Prepare and submit regulatory documents to FDA, DOH, PRC, LGUs, and other agencies.
- Maintain and monitor company permits, licenses, and accreditations.
- Ensure compliance for pharmaceuticals, medical devices, and laboratory-related products.
- Assist in audits, inspections, and ISO-related documentation and processes.
- Support internal ISO requirements such as SOPs, CAPA, and internal audits.
- Coordinate with internal teams to meet regulatory and ISO deadlines.
- Ensure proper documentation and compliance in pharmacy-related activities.
Qualifications:
- Licensed Pharmacist (PRC).
- At least 2 years of regulatory or compliance experience.
- Background in ISO processes or quality management systems.
- Knowledge of FDA, DOH, PRC, and LGU regulatory requirements.
- Strong documentation, coordination, and communication skills.
