Regulatory Pharmacist: FDA Submissions & Compliance

TOKAGAWA GLOBAL CORPORATION; Philippines; On-site; PHP 600,000 - 1,100,000; Full time

Job summary

You will work with suppliers, manufacturers, and internal teams to stay ahead of regulatory changes, manage deadlines, and maintain proper documentation.

Qualifications

• Bachelor's degree in Pharmacy is required.
• Licensed pharmacist in the Philippines is required.
• Experience in regulatory affairs for pharmaceutical products, medical devices, or healthcare goods is preferred.
• Experience coordinating with the Philippine FDA is a strong advantage.
• Knowledge of product registration, License to Operate, renewals, and variations.

Responsibilities

• Prepare, review, and submit regulatory applications to the FDA.
• Process registrations, renewals, variations, and other submissions for pharma products and medical devices.
• Monitor status of applications and follow up with FDA as needed.
• Respond to FDA notices, deficiencies, and document requests.
• Coordinate licensing and permits, including License to Operate.
• Review product dossiers, labels, and packaging before submission.
• Stay updated on FDA guidelines and regulatory changes.
• Serve as primary coordinator with FDA for submissions and inspections.
• Collaborate with suppliers, manufacturers, and internal teams.

Skills

Attention to detail

Communication skills

Time management

Regulatory knowledge

Education

Bachelor's degree in Pharmacy

Tools

Microsoft Office

Google Workspace

Document management systems

Online government submission platforms

Job description

You will work with suppliers, manufacturers, and internal teams to stay ahead of regulatory changes, manage deadlines, and maintain proper documentation.