Pharma Regulatory Affairs Specialist – Submissions

Manpower (Philippines); Philippines; On-site; PHP 420,000 - 660,000; Full time

Job summary

Manpower (Philippines) is seeking a detail-oriented Regulatory Affairs professional to support regulatory compliance, product submissions, and labeling activities within the pharmaceutical sector.

The role involves coordinating mock-up creation for labels, ensuring adherence to Philippine FDA requirements and labeling guidelines, preparing submissions to the FDA and supporting GMP clearance, and maintaining regulatory documentation and timelines with cross-functional teams.

Qualifications

• Experience in Regulatory Affairs within pharma/healthcare is preferred.
• Knowledge of Philippine FDA requirements and pharmaceutical regulations.
• Attention to detail with strong documentation and organizational skills.

Responsibilities

• Manage mock-up creation and artwork development for product labels, working with Labeling, QA, Marketing, Medical Affairs, and Supply Chain teams.
• Ensure product labels comply with internal and external labeling guidelines, regulations, and Philippine laws.
• Prepare and manage submissions to the Philippine FDA and support foreign GMP clearance applications.
• Ensure compliance with the Electronic Drug Price Monitoring System.
• Review drug product monographs for MIMS and PPD listings.
• Prepare accurate meeting minutes and regulatory documentation.
• Coordinate with cross-functional teams to ensure regulatory requirements and timelines are met.

Skills

Regulatory affairs experience

Philippine FDA compliance

Documentation skills

Cross-functional coordination

Written and verbal communication

Deadline management

Job description

Manpower (Philippines) is seeking a detail-oriented Regulatory Affairs professional to support regulatory compliance, product submissions, and labeling activities within the pharmaceutical sector.

The role involves coordinating mock-up creation for labels, ensuring adherence to Philippine FDA requirements and labeling guidelines, preparing submissions to the FDA and supporting GMP clearance, and maintaining regulatory documentation and timelines with cross-functional teams.