Executive Regulatory Affairs

Genedrift Philippines OP Corporation; Manila; On-site; PHP 360,000 - 600,000; Full time

Job summary

Genedrift Philippines OP Corporation in Metro Manila is seeking a regulatory submissions coordinator to prepare, review and compile dossiers for Health Authority submissions, both offline and online, under supervision.

This role ensures compliance with HA requirements and local laws for drugs, medical devices, cosmetics, and food supplements, and supports responses to supplements and queries from HA.

Qualifications

• Experience in regulatory submissions and document management is preferred.
• Strong attention to detail and ability to follow SOPs.

Responsibilities

• Prepare, review and compile dossiers for HA submissions, offline and online, under supervision.
• Ensure compliance with HA and local laws for drugs, devices, cosmetics and foods.
• Respond to HA supplements/queries and track application status.
• Maintain custody of original documents and records under guidance.
• Update internal docs with new guidelines and regulatory changes.
• Support team in effective communication with the HA.
• Monitor project deliverables and ensure SOPs are followed.
• Track project status and provide periodic updates to senior staff.

Job description

Preparation, review and compilation of dossiers for submissions to Health Authorities (HA), both offline/online, with supervision

Assist in ensuring compliance with HA, local laws/authorities for drugs, medical devices, cosmetics and food/health supplements

Support response to supplements/queries from HA and follow up on application status

Maintain upkeep and safe custody of original documents and records under guidance

Update internal documentation with reference to guidelines and regulatory changes

Support team management in effective communication with the HA

Assist in monitoring project deliverables and ensuring SOPs are followed

Track project status and provide periodic updates to senior team members