Premier Consulting
Arvin Mercado is a seasoned Regulatory Operations Manager at Premier Consulting, with extensive experience in regulatory submissions spanning notable positions at Gilead Sciences and Regulatory Professionals. At Gilead Sciences, Arvin demonstrated expertise in electronic submission compilation, training team members, and leading IND, NDA, and sBLA submissions. Arvin also played a pivotal role in developing tools for regulatory operations and enhancing training environments. Earlier experience includes supervisory and operational roles where Arvin led multiple initial submissions and coordinated projects to meet regulatory timelines. Prior to regulatory operations, Arvin worked as a QA Technician at Ghirardelli Chocolate Company, ensuring product quality and compliance. Arvin holds a Bachelor of Science in Food Science and Technology from the University of the Philippines.
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Premier Consulting
Premier Consulting is a strategic product development and global regulatory consulting brand dedicated to supporting the specialized needs of emerging biotech and specialty pharma companies. These small to midsize companies are the very heart of drug development. Like them, we are dedicated to the patient journey and are driven by the challenges of bringing new life-saving technologies to market. Informed by our Built for Biotech™ core capabilities, we deliver end-to-end strategy, regulatory, nonclinical, CMC, quality, and commercial solutions that are best in class. With a customer-centric culture, we couple efficiency with quality as we guide sponsors every step of the way to commercialization. We tailor development plans to meet the most rigorous global regulatory requirements and deliver results for sponsors - and the patients they serve. Premier Consulting is a business unit of Premier Research.