Pharmacist - Regulatory Affairs Associate

Prosel Pharmaceuticals and Distributors, Inc.; Las Piñas; On-site; PHP 400,000 - 660,000; Full time

Job summary

Prosel Pharmaceuticals and Distributors, Inc. is seeking a Regulatory Affairs professional in the Philippines to ensure regulatory compliance of products and operations through timely submissions, documentation, monitoring, and reporting.

The role collaborates with Regulatory Affairs, Supply Chain, Sales, suppliers, manufacturers, and government agencies (FDA) to support registration, maintenance, and recalls.

Qualifications

• Graduate of Pharmacy or related course and must be a licensed Registered Pharmacist (RPh).
• Strong problem-solving and interpersonal skills to handle regulatory issues and stakeholder management.
• Excellent organizational and time management abilities with meticulous attention to detail.
• Ability to handle confidential information and maintain data integrity.
• Knowledge of regulatory submissions, documentation, and compliance processes.

Responsibilities

• Prepare, process, and monitor regulatory submissions for product registrations, renewals, variations, licenses, clearances, and certifications in compliance with FDA, DOH, and other regulatory requirements.
• Monitor regulatory compliance and ensure complete and up-to-date documentation for product transfers, sampling, returns, recalls, inspections, and audits.
• Coordinate with suppliers, manufacturers, and internal departments regarding regulatory requirements, updates, and compliance matters.
• Assist in handling product complaints, regulatory concerns, risk assessments, and product recall activities, including required FDA reporting.
• Maintain organized regulatory databases, records, reports, and product documentation in accordance with company policies and regulatory standards.
• Conduct regulatory research and provide relevant information and recommendations to support new product initiatives and compliance improvements.
• Provide guidance to employees on regulatory processes and requirements.
• Assist the Regulatory Affairs Lead and Supply Chain team during regulatory inspections and other compliance activities.

Skills

Problem solving

Stakeholder mgmt

Organization

Attention to detail

Confidential info handling

Inventory management

Storage & distribution

Regulatory standards

MS Office

Education

Pharmacy degree / licensed Pharmacist (RPh)

Tools

MS Office

Job description

Job Summary:

The Regulatory Affairs role is responsible for ensuring regulatory compliance of the company's products and operations through timely submissions, documentation, monitoring, coordination, and regulatory reporting. The position works closely with the Regulatory Affairs, Supply Chain, Sales, suppliers, manufacturers, and government regulatory agencies, particularly the FDA, to ensure compliance with applicable requirements and support product registration, maintenance, and recall activities.

Key Responsibilities:

• Prepare, process, and monitor regulatory submissions for product registrations, renewals, variations, licenses, clearances, and certifications in compliance with FDA, DOH, and other regulatory requirements.

• Monitor regulatory compliance and ensure complete and up-to-date documentation for product transfers, sampling, returns, recalls, inspections, and audits.

• Coordinate with suppliers, manufacturers, and internal departments regarding regulatory requirements, updates, and compliance matters.

• Assist in handling product complaints, regulatory concerns, risk assessments, and product recall activities, including required FDA reporting.

• Maintain organized regulatory databases, records, reports, and product documentation in accordance with company policies and regulatory standards.

• Conduct regulatory research and provide relevant information and recommendations to support new product initiatives and compliance improvements.

• Provide guidance to employees on regulatory processes and requirements.

• Assist the Regulatory Affairs Lead and Supply Chain team during regulatory inspections and other compliance activities.

About you

• Graduate of Pharmacy or a related course and must be a licensed Registered Pharmacist (RPh).

• Good problem-solving skills to handle simple to moderate regulatory issues

• Good interpersonal skills for stakeholder management

• Organization and Time Management

• Attention to detail

• Able to handle confidential information

• Inventory Management

• Good Storage and Distribution Practices

• Regulatory Standards

• MS Office Proficient