PRODUCT DEVELOPMENT & REGULATORY OFFICER

Our company is a trusted provider of innovative medical devices and supplies. We are seeking a dual-functional Product Development & Regulatory Officer to lead our product lifecycle strategy and ensure 100% compliance with Philippine regulatory standards. This

role is critical in bridging the gap between our suppliers, government agencies (FDA, PDEA, DOH), and our sales force.

Key Responsibilities

I. Regulatory Affairs & Government Liaison

• Regulatory Compliance: Secure and maintain all necessary licenses and registrations, including LTO and CPR, from the FDA, PDEA, DOH, DDB, and the Bureau of Customs (BOC).
• Documentation: Manage the end-to-end collection of technical data from suppliers for

pre-registration and renewal processes.

• IP Management: Facilitate and monitor the registration process with the Intellectual Property Office (IPO).
• Quality Assurance: Ensure the company’s facility and processes consistently meet Good Warehousing Practices (GWP) and established Standard Operating Procedures (SOPs).

II. Product Development & Strategy

• Portfolio Expansion: Lead research and development initiatives to identify and launch new medical products that meet market needs.
• Supply Chain Coordination: Manage importation through coordination with supplier, broker, shipping company and forwarder. Manage relationships with various logistic partners regarding order confirmation, payment details ( in coordination with accounting department), shipping, product availability timelines, product labeling, packaging, and the resolution of product defects or recalls.
• Market Integration: Collaborate with the Sales and Marketing departments to develop visual and technical training materials for product launches.

III. Operational Support & Inventory Management

• Inventory Control: Conduct monthly physical inventory audits to ensure stock accuracy and support demand forecasting.
• Public Bidding: Assist in the preparation of technical documents and requirements for Government Bid opportunities.
• General Operations: Provide administrative support for invoicing and order fulfillment as needed to maintain operational flow.

Qualifications

• Must have at least 4 years experience as Regulatory Affairs Officer in a Pharmaceutical or Medical Equipment Company
• Knowledgeable in processing, registering and renewal of products registration with FDA and PDEA
• Experience in importation and bid documents preparation is an advantage
• Must be a Licensed Pharmacist

What we offer

• Competitive salary & benefits
• Career growth and professional development
• Opportunity to work in a fast-growing healthcare industry