Phil is a scientifically trained and industry-experienced attorney and counselor with a robust mix of FDA and private sector experience. He has worked in global large-cap, mid-size specialty and closely held innovator companies and global consulting. With nearly 20 years of professional experience, Phil has accumulated extensive knowledge in applying laws, regulations, and policies to pharmaceutical product development, the drug approval process, product quality regulatory submissions, chemistry, manufacturing, and controls (CMC) strategy, and drug manufacturing compliance and enforcement.
Phil readily identifies and capably resolves complex legal, regulatory, and technical issues in a high-risk and heavily regulated environment. He has a proven record of counseling and communicating with organizations on analyzing issues at the interface of life sciences, law, regulation, and business. He has created successful technical, regulatory, and compliance strategies for all pharmaceutical product life cycle management phases, assessed and integrated new product acquisitions, and led and grew new business acquisitions.
Phil’s diversified background has forged abilities that enable him to flourish as a team leader and contributor reliably. He can work under pressure and meet deadlines, systematically plan and organize, remain flexible and adapt while achieving critical goals, and assiduously keep a service-oriented client focus.
Phil is admitted to the California Bar and U. S. District Court for the Central District of California. With his wealth of experience, he can provide comprehensive legal and regulatory counsel to FDA-regulated industries. In addition to his work in the private sector, Phil also served as a Regulatory Counselor and a CMC Policy Analyst for the FDA earlier in his career. While at the FDA, Phil gained a deep understanding of the regulatory process for pharmaceutical product development, approval, and compliance. He played an instrumental role in advising the FDA on complex legal and technical issues related to CMC strategy and drug manufacturing compliance and enforcement.
His time at the FDA gave him a unique perspective on the regulatory landscape he brings to his work as an attorney and counselor to the FDA-regulated industry. Phil’s experience as a regulator and a private sector attorney allows him to approach legal and regulatory issues from multiple angles and provide comprehensive guidance to his clients. He is highly respected in the industry for his expertise and ability to navigate complex legal and regulatory frameworks easily.