Senior Regulatory Affairs Specialist: Global Submissions

half the sky; Manila; On-site; PHP 669,600 - 892,800; Full time

Job summary

A pharmaceutical company based in Metro Manila is seeking a Senior Specialist in Regulatory Affairs. This role entails managing all regulatory submissions for pharmaceutical products and acting as the primary point of contact with health authorities. The ideal candidate will have expertise in local regulatory requirements and demonstrate strong collaboration skills to ensure compliance across departments. Responsibilities include preparing applications, maintaining regulatory licenses, and supporting local audits. Competitive benefits and opportunity for growth are offered.

Qualifications

• Experience in Regulatory Affairs for pharmaceuticals or medical devices.
• Familiarity with local health authority application processes.
• Ability to collaborate across departments to ensure compliance.

Responsibilities

• Manage Regulatory Affairs submissions for assigned products.
• Liaise with health authorities for submission requirements.
• Ensure compliance with local laws and regulations.
• File and archive safety-related regulatory documents.
• Support audits and inspections for compliance.

Skills

Regulatory Affairs knowledge

Submission requirements management

Compliance with local regulations

Cross-functional collaboration

Audit readiness

Job description

A pharmaceutical company based in Metro Manila is seeking a Senior Specialist in Regulatory Affairs. This role entails managing all regulatory submissions for pharmaceutical products and acting as the primary point of contact with health authorities. The ideal candidate will have expertise in local regulatory requirements and demonstrate strong collaboration skills to ensure compliance across departments. Responsibilities include preparing applications, maintaining regulatory licenses, and supporting local audits. Competitive benefits and opportunity for growth are offered.