PRODUCT DEVELOPMENT & REGULATORY OFFICER

Janissa Healthcare Philippines, Inc.; Pasig; On-site; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary & benefits

Career growth and development

Healthcare industry experience

Job summary

Janissa Healthcare Philippines, Inc. is seeking a dual-functional Product Development & Regulatory Officer to lead our product lifecycle strategy and ensure 100% compliance with Philippine regulatory standards.

This role bridges suppliers, government agencies (FDA, PDEA, DOH), and the sales force from an on-site Pasig location. The ideal candidate has 4+ years of regulatory affairs experience in pharma or medical devices and must be a licensed pharmacist, with responsibilities spanning

Qualifications

• At least 4 years as Regulatory Affairs Officer in a Pharmaceutical or Medical Equipment company.
• Knowledge of processing, registering and renewal of product registrations with FDA and PDEA.
• Experience in importation and bid documents preparation is an advantage.
• Must be a Licensed Pharmacist.

Responsibilities

• Secure and maintain licenses and registrations (FDA, PDEA, DOH, BOC, etc.).
• Manage end-to-end collection of technical data from suppliers for pre-registration/renewals.
• Facilitate IPO registrations and monitor IP filings.
• Ensure facilities/ processes meet Good Warehousing Practices and SOPs.
• Lead R&D to identify and launch new medical products.
• Coordinate imports and logistics with suppliers, brokers, and forwarders.
• Support market launches with training materials for Sales & Marketing.
• Conduct monthly inventory audits and support demand forecasting.
• Assist in preparing documents for Government Bid opportunities.

Skills

Regulatory affairs

FDA registration

Documentation management

IP management

Quality assurance

Education

Licensed Pharmacist

Job description

PRODUCT DEVELOPMENT & REGULATORY OFFICER

On-site - Pasig 3-5 Yrs Exp Bachelor Full-time

Job Description

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

• Regulatory Compliance:Secure and maintain all necessary licenses and registrations, includingLTOandCPR, from theFDA, PDEA, DOH, DDB,and theBureau 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 theIntellectual Property Office (IPO).
• Quality Assurance:Ensure the company’s facility and processes consistently meetGood Warehousing Practices (GWP)and establishedStandard Operating Procedures (SOPs).
• 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 forGovernment 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

Preview

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