Regulatory Pharmacist

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

About the role

The Regulatory Pharmacist will manage and coordinate regulatory requirements for pharmaceutical products and medical devices. The role is responsible for preparing, reviewing, submitting, and monitoring applications and documents filed with the Philippine Food and Drug Administration and other relevant government agencies. The Regulatory Pharmacist will work closely with suppliers, manufacturers, internal departments, and regulatory authorities to ensure that products, licenses, registrations, and company operations remain compliant with applicable regulations.

Key responsibilities

• Prepare, review, organize, and submit regulatory applications to the Philippine Food and Drug Administration
• Process new applications, renewals, amendments, variations, and other regulatory submissions for pharmaceutical products and medical devices
• Monitor the status of pending applications and follow up with the FDA as necessary
• Respond to FDA notices, deficiencies, clarifications, and additional document requirements
• Handle applications for product registration, notification, listing, licensing, and other required authorizations
• Review product dossiers, technical documents, certificates, labels, packaging materials, and product information before submission
• Assist in the application, maintenance, amendment, and renewal of the company's License to Operate and other necessary permits
• Determine the appropriate regulatory classification and requirements for medical devices
• Stay updated on new FDA issuances, administrative orders, circulars, guidelines, and regulatory requirements
• Serve as the company's primary coordinator with the FDA for regulatory submissions, inquiries, inspections, and follow-ups

About you

• Bachelor's degree in Pharmacy
• Must be a licensed pharmacist in the Philippines
• Experience in regulatory affairs involving pharmaceutical products, medical devices, food supplements, cosmetics, or healthcare products is preferred
• Previous experience coordinating with the Philippine FDA is a strong advantage
• Knowledge of product registration, License to Operate applications, renewals, variations, and regulatory documentation
• Strong attention to detail and ability to manage multiple applications and deadlines
• Excellent written and verbal communication skills in English and Filipino
• Proficient in Microsoft Office, Google Workspace, document management, and online government submission platforms
• Highly organized, responsible, discreet, and capable of working with minimal supervision