Regulatory Affairs Admin Assistant - Office-Based (4x/wk)

Concrete Masters, Inc.; Manila; Hybrid; PHP 279,000 - 446,000; Full time

Job summary

ICON is a global healthcare intelligence and clinical research organisation dedicated to bringing new medicines and treatments to patients faster. We are seeking a Regulatory Affairs Admin Assistant to support regulatory operations, product registrations, and lifecycle management.

You will coordinate regulatory submissions, maintain compliance documentation, monitor application progress, and assist post-approval regulatory activities while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Minimum of 1 year of experience in regulatory affairs within the pharmaceutical or biotechnology industry
• Understanding of regulatory submissions, product registrations, renewals, and post-approval maintenance activities
• Strong attention to detail and excellent communication skills
• Willingness to work on Office-based setup (4x a week RTO at client office in BGC)

Responsibilities

• Manage regulatory document archiving, retrieval, and records maintenance activities.
• Process payment requests and coordinate regulatory application fees with internal stakeholders.
• Prepare, compile, and submit regulatory applications and supporting documentation to health authorities.
• Monitor regulatory application statuses and proactively follow up on pending approvals and submissions.
• Support regulatory document requests related to business opportunities, tenders, and formulary inclusion activities.
• Coordinate notarization and certification of regulatory documents when required.
• Track and maintain incoming compliance documents, including certificates, licenses, authorizations, and quality-related documentation.
• Maintain regulatory databases, document repositories, and product master records to ensure accuracy and compliance.
• Upload, organize, and maintain regulatory documentation within electronic document management systems.
• Perform regulatory data updates and support ongoing records maintenance activities.
• Support Product Lifecycle Management activities, including post-approval changes, minor variations, renewals, and maintenance of product registrations.
• Ensure regulatory records are complete, current, and inspection-ready.
• Collaborate cross-functionally to support regulatory compliance and product registration objectives.

Skills

Regulatory affairs

Attention to detail

Communication skills

Office-based readiness

Education

Bachelor's degree in science/healthcare

Job description

ICON is a global healthcare intelligence and clinical research organisation dedicated to bringing new medicines and treatments to patients faster. We are seeking a Regulatory Affairs Admin Assistant to support regulatory operations, product registrations, and lifecycle management.

You will coordinate regulatory submissions, maintain compliance documentation, monitor application progress, and assist post-approval regulatory activities while collaborating with cross-functional teams.