Cambert (Pilipinas), Inc. is looking for a Regulatory Affairs & FDA Liaison Officer who will be responsible for managing and facilitating the company's regulatory requirements with the Philippine Food and Drug Administration (FDA) and other relevant government agencies.
The role will support the registration, notification, renewal, and regulatory compliance of the company's portfolio of imported healthcare, personal care, skincare, cosmetic, medical device, and applicable OTC/consumer health products. The successful candidate will work closely with internal teams and international principals to ensure regulatory requirements are completed accurately and on time.
Key responsibilities include the follwoing:
- Manage and facilitate FDA applications across applicable product categories, including cosmetics/personal care, medical devices, and applicable OTC/consumer health products, covering new applications, renewals, amendments, notifications, registrations, and other regulatory submissions.
- Process and monitor License to Operate (LTO) applications, renewals, and related regulatory requirements.
- Handle Cosmetic Product Notification (CPN) applications and applicable medical device notification/registration applications (including CMDN/CMDR, as applicable), together with related renewals, amendments, and supporting requirements.
- Determine and monitor the appropriate Philippine FDA regulatory pathway for medical devices, including device classification and the documentation required for notification or registration, as applicable.
- Coordinate and follow up with the FDA and other relevant government agencies regarding pending applications, clarifications, deficiencies, and regulatory concerns.
- Review product information, formulations or specifications, labels, packaging materials, claims, technical documents, and supporting documents for compliance with applicable Philippine regulations and the relevant product category.
- Coordinate with international principals and manufacturers to secure regulatory documents and address deficiencies or additional requirements.
- Maintain complete and organized regulatory files for all brands and products.
- Maintain an updated regulatory tracker covering application status, registration/notification details, expiration dates, renewal schedules, pending requirements, and regulatory issues.
- Proactively monitor upcoming renewals and regulatory deadlines to prevent lapses in product registrations, notifications, and licenses.
- Monitor FDA issuances, advisories, regulations, and other regulatory developments relevant to the company's products and operations.
- Provide regulatory guidance to Marketing, Sales, Supply Chain, and other internal teams during new product development and product launches, including identification of the appropriate regulatory pathway and requirements for cosmetics, medical devices, and applicable consumer health products.
- Review proposed product claims and marketing materials from a regulatory compliance perspective when necessary.
- Identify potential regulatory risks or issues and escalate them to management with recommended courses of action.
- Prepare and present a weekly regulatory status report covering completed activities, pending applications, outstanding requirements, deadlines, issues, risks, and required next steps.
- Represent the company professionally during transactions and coordination with regulatory authorities.
- Perform other regulatory and compliance-related responsibilities as may be assigned.
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