Regulatory Affairs

Global Quest Consulting Group; Hinatuan; On-site; PHP 420,000 - 640,000; Full time

Job summary

Global Quest Consulting Group is seeking a Regulatory Affairs Pharmacist to ensure compliance of company products and processes with local and international requirements. You will monitor regulatory changes, prepare dossiers, and support audits and inspections.

The role requires a licensed pharmacist with 1–2 years in regulatory affairs or FDA registration, strong document control, and excellent communication and leadership skills. Based in Greenhills, San Juan City, Metro Manila.

Qualifications

• Licensed Pharmacist with strong regulatory knowledge.
• 1–2 years of regulatory affairs or FDA registration experience preferred.

Responsibilities

• Ensure company products and processes comply with applicable laws, regulations, standards, and guidelines.
• Monitor changes in regulatory and compliance requirements and assess their impact on existing and new products.
• Support internal audits, regulatory inspections, and compliance reviews.
• Maintain proper document control systems, SOPs, and compliance records.
• Prepare, compile, review, and maintain regulatory dossiers in compliance with local and international regulatory requirements.
• Manage product registration, renewal, variation, and amendment submissions with relevant regulatory authorities.

Skills

Regulatory affairs

FDA registration

Regulatory documentation

Leadership

Communication

Education

Licensed Pharmacist

Job description

• Ensure company products and processes comply with applicable laws, regulations, standards, and guidelines (e.g., health authority, procurement, and quality regulations).
• Monitor changes in regulatory and compliance requirements and assess their impact on existing and new products.
• Support internal audits, regulatory inspections, and compliance reviews.
• Maintain proper document control systems, SOPs, and compliance records.
• Prepare, compile, review, and maintain regulatory dossiers in compliance with local and international regulatory requirements.
• Manage product registration, renewal, variation, and amendment submissions with relevant regulatory authorities.
• Licensed Pharmacist
• Preferably with 1-2 years of experience in regulatory affairs or FDA registration of pharmaceutical or medical supplies
• Knowledgeable in regulatory documentation, product registration, compliance processes, and government hospital bidding.
• Computer literate and highly organized, with strong analytical and problem-solving skills.
• Excellent communication, coordination, and leadership abilities.
• Proactive, detail-oriented, and capable of handling multiple tasks efficiently.
• Willing to be assigned in Greenhills, San Juan City, Metro Manila.