Regulatory Affairs Specialist – Pharma, San Juan Onsite

Global Quest Consulting Group; San Juan (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A consulting firm is seeking a licensed pharmacist in San Juan to ensure compliance with regulatory requirements for pharmaceutical products. You will monitor regulatory changes, support audits, and maintain document control systems. The ideal candidate will have 1-2 years of experience in regulatory affairs, strong analytical and problem-solving skills, and excellent communication and leadership abilities. This is a full-time on-site role in San Juan, Puerto Rico.

Qualifications

• 1-2 years of experience in regulatory affairs or FDA registration of pharmaceutical or medical supplies.
• Proactive, detail-oriented, and capable of handling multiple tasks efficiently.
• Knowledgeable in regulatory documentation, product registration, compliance processes, and government hospital bidding.

Responsibilities

• Ensure company products comply with laws, regulations, and standards.
• Monitor changes in regulatory requirements and assess their impact.
• Support internal audits and regulatory inspections.

Skills

Regulatory documentation

Compliance processes

Strong analytical skills

Excellent communication abilities

Organizational skills

Education

Bachelor's degree

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 inregulatory documentation, product registration, compliance processes, and government hospital bidding.
• Computer literate and highly organized, with strong analytical and problem-solving skills.
• Excellentcommunication, coordination, and leadership abilities.
• Proactive, detail-oriented, and capable of handling multiple tasks efficiently.
• Willing to be assigned inGreenhills, San Juan City, Metro Manila.
• Salary : Negotiable