Regulatory Affairs Officer

Diagnostika Pilipinas, Inc.; Philippines; On-site; PHP 600,000 - 900,000; Full time

Job summary

Diagnostika Pilipinas, Inc. is seeking a Regulatory Affairs/Pharmacist Officer in the Philippines to ensure compliance with FDA, DOH, PDEA, and other regulatory bodies. This desk-based role involves evaluating scientific and legal documents and coordinating licensing activities.

The successful candidate will prepare registrations, oversee QA systems, manage licenses, and liaise with partners while keeping up-to-date with regulations and best practices in the pharmaceutical field.

Qualifications

• Must hold a valid Pharmacist license and degree in Pharmacy.
• Solid knowledge of Philippine FDA, DOH, PDEA regulations.
• Experience with importation, licensing, and product registrations.

Responsibilities

• Serve as Regulatory Affairs liaison between the company and partners.
• Prepare, process, and facilitate registration and licensing of diagnostic products and equipment with FDA/DOH.
• Review product information and licensing activities for all product segments.
• Design and implement regulatory strategies to meet licensing timelines.
• Maintain QA systems, SOPs, and risk management for inventory and shipments.
• Process permits with PDEA for importation and hazardous waste management.

Skills

Regulatory affairs

Licensed Pharmacist

Regulatory compliance

Attention to detail

Communication skills

Education

Bachelor's degree in Pharmacy

Tools

Microsoft Office

Google Sheets

Job description

Job Description:

Regulatory Affairs/Pharmacist Officer ensures that the company complies with applicable FDA,DOH, PDEA, OMB, Philippine Tariff Commission, Custom Importation and other regulatory-related government entities regulations on licenses, technical documents, and product registrations. They are also responsible for the preparation, evaluation, and submission of Initial applications. This is a desk-based role, involving the close study of scientific and legal documents.

Main Responsibilities:

• Act as Regulatory Affairs Liaison Officer between the company and all its business partners
• Prepare, process, and facilitate registration and licensing of diagnostic products laboratory equipment with the Food and Drug Administration (FDA), Department of Health (DOH), PDEA once new regulation for IVDs implemented
• To check product information and analysis based on the requirement of FDA and integrate review of licensing activities for every product segment
• Design and implement regulatory strategies to meet objectives and timelines set for licensing, registration of products and other related regulatory matters
• Peforms the duties as a responsible Pharmacist for Warehouse according to standards of Good distributions and good storage practice.
• Acts as the Internal Quality Assurance Officer to design and Implement all Quality Assurance (QA) Systems, Standard Operating Procedures and RMP (Risk Management Plan) for current and inbound inventory as well as inspection of outbound deliveries and product-returns; to help in the creation of Standard Operating.
• To process the necessary permits with the Philippine Drug Enforcement Agency (PDEA) needed for importation, permits for expired waste disposal such as Permit to Transport, Hazardous Waste Manifest and to keep abreast of the laws and policy-related information on Hazardous Waste Management System as prescribed by the Department of Environment and Natural Resources (DENR).
• To process renewal of government licenses (Bureau of Customs, Client Profile Registration System, FDA e-portal, PhilGEPS).
• Coordination with brokers for the incoming shipment by submitting necessary permits and certifications from FDA, NTC and OMB as per compliance with the Bureau of Customs.
• Assists in inventory monitoring and checking of in and out of stocks, incoming shipments from supplier and outgoing shipments to customer including transfer of stocks in Visayas and Mindanao.
• Coordination with outbound logistics for shipment of stocks via PAL, Cebu Pacific or third party forwarder and make sure all are supported with MSDS.
• Organize and manage all digital and physical data/files from manufacturers and distributors
• Provide and update daily training module and activities based on updated RPh acquired knowledge
• To act as marketing support by reviewing -product related information and article for social media and website posting
• Maintains safe and clean working environment by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
• Contributes to team effort to perform other tasks as assigned by accomplishing related results as needed

Qualifications:

• Bachelor's degree in Pharmacy, Must be a Licensed/Registered Pharmacist
• Strong understanding of Philippine FDA regulations and guidelines
• Knowledged in PDEA, BOC (Bureau of Customs) and other authorities in relation to importation and custom clearance
• Stay current on evolving regulatory requirements and industry best practices.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Google Sheets
• Strong understanding of the international regulations and standards particularly for global medical device companies
• Good written and verbal communication skills, with the ability to communicate complex technical information clearly and concisely
• Strong attention to detail and ability to manage multiple tasks efficiently
• Ability to work independently as well as collaboratively within a team environment
• Highly self-motivated, goal-oriented, and committed to pursuing a lo