Mikaela Laysa

@qrasolutions

Quality Assurance Regulatory Affairs Manager

Philippines

English, Tagalog

About me

I am a Registered Pharmacist and Quality & Regulatory Affairs leader with over 10 years of experience in pharmaceutical, manufacturing, and distribution environments. I have a proven record of leading regulatory compliance, managing 120+ Initial, Amendment and Renewal product registrations, and implementing QMS and GMP systems. I specialize in liaising with government agencies like the FDA and BAI to ensure full operational readiness.... Read more

Skills

Regulatory affairs expert
Quality assurance expert
HACCP expert
Product developer
Supply chain manager

Mikaela Laysa

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Average response time: 1 hour

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Technical Writing

I will review your documents for approval and compliance

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Mikaela Laysa