Regulatory Pharmacist

TOKAGAWA GLOBAL CORPORATION

Makati

On-site

PHP 600,000 - 900,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

TOKAGAWA GLOBAL CORPORATION seeks a detail-oriented Regulatory Pharmacist to manage regulatory requirements for pharmaceutical products and medical devices in the Philippines. The role involves preparing, reviewing, submitting, and monitoring applications with the FDA and other agencies.

You will work with suppliers, manufacturers, and internal teams to ensure products, licenses, and company operations remain compliant with regulations. Strong communication in English and Filipino is essential.

Qualifications

Bachelor’s degree in Pharmacy and Philippine pharmacist license.
Experience in regulatory affairs for pharma, medical devices, or healthcare products is preferred.
Knowledge of product registration, License to Operate, renewals, variations, and regulatory documentation.
Excellent written and verbal communication in English and Filipino.

Responsibilities

Prepare, review, organize, and submit regulatory applications to the FDA and other agencies.
Process new applications, renewals, variations, and other regulatory submissions for pharmaceutical products and medical devices.
Monitor status of pending applications and follow up with FDA as needed.
Ensure submissions are complete, properly formatted, and filed on time.
Maintain regulatory records of submission numbers, dates, payments, approvals, and expirations.
Coordinate regulatory requirements for importation, distribution, and sale of registered products.

Skills

Attention to detail

English and Filipino communication

Regulatory coordination

Microsoft Office / Google Workspace

Education

Bachelor’s degree in Pharmacy

Tools

Microsoft Office

Google Workspace

Document management

Online government submission platforms

Job description

Regulatory Pharmacist

Job Summary

We are looking for a detail-oriented and experienced Regulatory Pharmacist to manage and coordinate regulatory requirements for pharmaceutical products and medical devices. The role will be 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

FDA Applications and Submissions

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.
Ensure that submissions are complete, accurate, properly formatted, and filed within the required timelines.
Maintain updated records of application numbers, submission dates, payment references, approval dates, and expiration dates.

Product Registration

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.
Coordinate with local and foreign manufacturers or suppliers to obtain the required regulatory documents.
Ensure that product claims, indications, specifications, labeling, and packaging comply with applicable requirements.
Monitor product registration validity and prepare renewal applications before expiration.
Coordinate regulatory requirements for the importation, distribution, and sale of registered products.

Company Licensing and Compliance

Assist in the application, maintenance, amendment, and renewal of the company’s License to Operate and other necessary permits.
Ensure that the company complies with the conditions of its licenses and regulatory approvals.
Monitor changes in company information, warehouse locations, authorized activities, product lines, or responsible personnel that may require regulatory amendments.
Maintain organized and updated regulatory files for inspection, audit, and internal reference.
Coordinate with management regarding compliance issues, regulatory risks, and upcoming deadlines.

Medical Device Regulatory Support

Determine the appropriate regulatory classification and requirements for medical devices.
Prepare and submit applications for medical device registration, notification, listing, amendments, and renewals.
Review device specifications, intended use, certificates, technical documentation, labeling, instructions for use, and manufacturer information.
Coordinate with manufacturers and suppliers regarding missing, expired, or incomplete documents.
Ensure that medical device promotional materials and product claims are consistent with approved uses and registrations.

Pharmaceutical Regulatory Support

Prepare and review documents required for pharmaceutical product applications.
Coordinate the collection of product information, certificates, manufacturing documents, specifications, test reports, labeling, and supporting records.
Review proposed packaging, inserts, product information, and promotional claims for regulatory compliance.
Monitor regulatory requirements affecting the importation, distribution, storage, marketing, and sale of pharmaceutical products.
Assist in managing regulatory matters involving product changes, renewals, recalls, complaints, or safety concerns.

Regulatory Monitoring

Stay updated on new FDA issuances, administrative orders, circulars, guidelines, and regulatory requirements.
Inform management and relevant departments of regulatory changes that may affect company operations or products.
Recommend necessary actions to maintain compliance with updated regulations.
Maintain a regulatory calendar covering product registrations, licenses, permits, renewals, submissions, and compliance deadlines.

Coordination and Communication

Serve as the company’s primary coordinator with the FDA for regulatory submissions, inquiries, inspections, and follow-ups.
Coordinate with purchasing, importation, sales, marketing, quality assurance, warehouse, finance, and management teams.
Work with suppliers and manufacturers to ensure the timely submission of complete regulatory documents.
Provide regulatory guidance to internal teams regarding product registration, labeling, marketing materials, and compliance requirements.
Prepare formal letters, explanations, declarations, responses, and other correspondence required by regulatory authorities.

Documentation and Recordkeeping

Maintain complete physical and electronic records of licenses, product registrations, applications, certificates, correspondence, and approvals.
Develop a reliable tracking system for regulatory submissions and expiration dates.
Ensure that confidential product, supplier, and regulatory documents are properly secured.
Prepare regular reports on application status, pending requirements, regulatory deadlines, and compliance concerns.
Ensure that approved product information and regulatory records are accessible to authorized departments.

Post-Market Compliance

Assist in handling product complaints, adverse event reports, recalls, safety notices, and regulatory investigations.
Coordinate the collection and submission of required post-market surveillance information.
Ensure that product changes, manufacturer changes, labeling revisions, and other variations are properly reported or approved.
Support company responses during FDA inspections, audits, and compliance reviews.
Immediately report significant regulatory risks or potential violations to management.

Qualifications

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.
Able to communicate professionally with government agencies, suppliers, manufacturers, and internal departments.
Highly organized, responsible, discreet, and capable of working with minimal supervision.

Key Performance Expectations

The Regulatory Pharmacist will be evaluated based on: