Regulatory Affairs Specialist
Full-time
Paragon Care Philippines, Inc.
About the role
Paragon Care Philippines, Inc. is looking for a detail-oriented and proactive Regulatory Affairs Specialist to manage regulatory compliance and product registration activities across our growing business. The successful candidate will handle Philippine FDA applications, product registrations, licensing, renewals, and regulatory documentation for medical devices, pharmaceutical products, cosmetics, food, and health supplements, as applicable.
Key responsibilities
- Prepare, review, and submit Philippine FDA applications for product registrations, License to Operate (LTO), renewals, variations, and other regulatory requirements
- Prepare, compile, review, and maintain regulatory dossiers and supporting documents
- Coordinate with overseas manufacturers and suppliers to obtain the documents required for regulatory submissions
- Review product labels, packaging artwork, product information, and promotional materials for regulatory compliance
- Prepare and review Standard Operating Procedures (SOPs), Risk Management Plans (RMPs), and other regulatory documents, as applicable
- Liaise with the Philippine FDA and other relevant government agencies regarding submissions, regulatory queries, and approvals
- Monitor product registration status, license validity, renewal deadlines, and submission timelines
- Monitor regulatory updates and assess their impact on the company's products and business operations
- Maintain accurate records of regulatory submissions, licenses, approvals, and correspondence
- Provide regulatory support for product launches, importation, distribution, and ongoing product compliance
About you
- Bachelor's degree in pharmacy or another relevant science-related field
- A valid PRC license is an advantage
- Preferably with at least 2–3 years of experience in Regulatory Affairs, Philippine FDA compliance, or product registration
- Experience with Philippine FDA registrations for medical devices, pharmaceutical products, cosmetics, food, or health supplements
- Knowledge of Philippine FDA regulations and requirements for product registration, LTO applications, labeling, renewals, and regulatory documentation
- Experience preparing product dossiers and coordinating with overseas manufacturers or suppliers is preferred
- Strong organizational, analytical, and documentation skills, with excellent attention to detail
- Good written and verbal communication skills
- Proficient in Microsoft Office applications
- Able to work independently, manage multiple priorities, identify missing requirements, and meet deadlines
About us
Paragon Care Philippines, Inc. is a growing business managing regulatory compliance and product registration activities across medical devices, pharmaceutical products, cosmetics, food, and health supplements.
Vacancy posted 1 day ago
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