Senior Director/Global Regulatory Lead - Responsible for developing global regulatory strategy for various projects, working with the Global Regulatory Team, and participating as a member of cross-functional project teams on regulatory issues associated with projects.

Previously, had the pleasure of working with a high-performing leadership team focused on providing high-quality services that meet or exceed client expectations in the pharmaceutical and medical device industry. This company has some of the brightest and best professionals that I have ever worked with in my career. Highly business focused, extensive hands-on experience, a drive for success, great reputation, highest levels of technical acumen, and proven track record for project completion and client satisfaction. After 20 years plus experience in the pharmaceutical and medical device industry in quality and regulatory affairs, I still enjoy my career immensely. It is exciting to continue to navigate through the quality and regulatory complexities inherent in Industry today. With all of the challenges ahead, this team of professionals is certainly capable of solving and resolving issues. It is certainly a pleasure to be part of this winning team.In the past, I was very fortunate to have had the opportunity to lead a team in the development and implementation of one of the largest multi-site ISO 9001 certified Quality Management Systems in the world. Successful experience in implementing global regulatory compliance programs, internal audit programs, etc. Worked with a team of highly experienced and qualified individuals, resulting in an excellent compliance record. Experienced with Drug Master Files, Master Files for devices, Pre-market notifications 510(k) submissions, NDAs, ANDAs, Comparability Protocols, etc. Experience with post-approval changes; specifically, reduced reporting categories. Additional experience and expertise in quality and compliance with industrial, electronic and food grade products, consumer products.

-Built and implemented highly effective global strategic plans and programs for regulatory compliance that align with the business objectives of the organization-Served as a senior consultant/adviser to current organizations customers – advising on global regulatory strategies and submissions-Worked very effectively as senior/executive leadership team member; providing truncated version of cGMP and QS training-Worked successfully in matrix management environment-Developed and has implemented programs that have expedited regulatory submissions for large domestic and international bio/pharma organizations-Defined and implemented annual cGMP and QS training initiatives across entire company-Conducted joint training with FDA on Combination products cGMP compliance-Invited and conducted in-house training for CFDA-Professional working relationships at FDA, HC, MHRA, EU, CFDA, etc.-Recognized as industry expert in cGMP’s

-Led a team in the successful development and implementation of one of the largest ISO 9001 based Quality Management Systems in the world-Built and implemented atypical audit program that has been effective in meeting regulatory requirements and expectation

Specialized in Adolescent Psychiatry. Worked with troubled teens, as well as adults; worked on patient treatment plans, assisted with group therapy instruction, monitoring patient care, etc. Also, worked private duty.