Regulatory Affairs, San Juan

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.
Salary : Negotiable

Highlights

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