Andrea E Chamblee

·         Certified Regulatory Affairs Professional, RAPS Fellow; Johns Hopkins University Professor.

·         Advises global company on all aspects of regulated medical products from concept to commercialization and reimbursement during mergers and growth.

·         Monitors regulatory activities, evaluates impact on development programs, and communicates assessment to top management. Provides insight into the regulatory environment and FDA activities, including current initiatives and emerging issues such as GMP for the 21st century, combination product approval, post-marketing requirements and FDA Modernization.

·         Works with interdisciplinary product teams to develop strategies and prepare for best outcomes from FDA submissions, inspections, and meetings; communicates to all levels throughout company.

·         Drafts internal processes and procedures to implement changes in US law or FDA policy.  Analyzes Federal Register (FR) notices and FDA Guidance to Industry to assess impact on drug and combination product business and products. Develops comments in response to draft FDA policies.

·         Facilitates interactions with FDA. Negotiates with FDA on inspections, data integrity, requirements affecting clinical trials, manufacturing, and promotion; drafts and analyzes laws, bills, and regulations on FDA and other administrative law issues and regulatory policy.

·         Trained inspector; editor, writer. Admitted: MD Bar (1986), DC (1989).  R.A.C. earned 1993.  Completed RAPS Executive Development Program, 2008. First class of RAPS Fellows, 2008.