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Roland Buhler, R.Ph.

RAC Senior Director, CMC Regulatory Affairs

Roland Buhler, R.Ph., RAC, has over 30 years in the pharmaceutical industry. As a CMC Regulatory Affairs professional and a licensed pharmacist, he brings an exceptional blend of technical knowledge and regulatory acumen. His qualifications have positioned him adeptly for overseeing intricate and varied initiatives, from the preliminary stages of Investigational New Drug (IND) applications to post-market authorization. He has lead teams through complicated regulatory processes to ensure compliance with global regulatory standards.

Before joining Syner-G, Roland has provided strategic guidance and operational support for developing and commercializing biologic and small molecule compounds for various therapeutic areas. He has successfully led teams through agency meetings, submissions, and inquiries, ensuring compliance with global standards and regulations, and has contributed to due diligence activities for in-licensing and acquisitions.

Prior to regulatory, he held several positions in quality assurance managing internal and external audit programming, compliance projects, and acquisition integrations. In this capacity, he directed high-level, risk-based assessments to determine strategy and remediation prioritization, managed consultants to develop a site master validation plan and organize inspectional history for upcoming agency inspections, and developed and maintained programs to identify and prioritize compliance risks that might result in business interruptions to existing commercial products or NDA approval delays.

Roland has managed various pharmaceutical dosage forms supporting biological and small molecules for investigational and marketed products within oncology, neuroscience, immunology, renal, and pain therapeutic areas.

As a team leader, he has managed personnel supporting anti-infective, cardiovascular, renal, and inhaled anesthetic products and was responsible for monitoring supplements, amendments, and variations for changes to manufacturing processes, test methods, manufacturing sites, or specifications.

Roland received his Bachelor of Science, Pharmacy, from the University of Wisconsin, Madison, WI. He also attended the University of Wisconsin, Milwaukee, WI, studying Computer Science, Mathematics, and Physics. He has been a member of the Regulatory Affairs Professional Society, Rockville, MD, since 2005.

Roland Buhler, R.Ph.'s Recent Articles

Why are Biologics Drugs Different

What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly provided for broader therapeutic use over the last few decades and this trend is accelerating. As the first part of…

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