Regulatory Affairs and FDA Liaison Officer  

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.

We are looking for someone who is organized, proactive, detail-oriented, dependable, and capable of working independently. The ideal candidate does more than follow up on applications - they understand the regulatory process, anticipate requirements, maintain accurate records, and help ensure that regulatory matters do not unnecessarily delay product launches or business operations.

The successful candidate should be comfortable taking ownership of regulatory applications from initial document preparation through submission, follow-up, approval, and renewal, while keeping management clearly informed of progress, risks, and required actions.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, Medical Technology, or another relevant science-related field.
• At least 2 years of relevant experience in Regulatory Affairs, FDA liaison work, product registration, or regulatory compliance.
• Hands-on experience processing applications and coordinating with the Philippine Food and Drug Administration (FDA).
• Experience with cosmetics, skincare, personal care, medical devices, healthcare, or OTC/consumer health products is highly preferred.
• Hands-on familiarity with Cosmetic Product Notification (CPN), License to Operate (LTO), and medical device notification/registration processes (including CMDN/CMDR, as applicable), as well as renewals and amendments, is highly preferred.
• Experience working with an importer, distributor, or multinational principal is an advantage.
• Familiarity with reviewing product formulations or specifications, ingredient lists, technical documentation, product labels, claims, and regulatory supporting documents is an advantage.
• Licensed Pharmacists are welcome to apply and will be considered an advantage; pharmacist licensure is not a general requirement for this position unless required for a specific regulatory responsibility assigned to the role.
• Strong organizational and document-management skills with excellent attention to detail.
• Able to manage multiple products, applications, deadlines, and regulatory requirements simultaneously.
• Strong written and verbal communication skills in English and Filipino.
• Comfortable communicating professionally with international suppliers/principals and government agencies.
• Proficient in Microsoft Excel, Word, and other standard office applications.
• Able to work independently with minimal day-to-day supervision, follow through on pending applications, and proactively identify potential regulatory issues.
• Must be disciplined and reliable in maintaining regulatory trackers and providing accurate weekly status reports.
• Willing and able to conduct onsite transactions and visits to FDA and other government offices when required.