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Well organized FDA/Consumer Safety Officer with more than 29 years progressively responsible experience in specialized areas of Natural Sciences, with strong background in legal court actions and agency hearings involving Federal rulings and guidelines. Experience includes in-depth domestic and foreign investigations analysis to determine compliance with Food, Drug and Cosmetic Act and Current Good Manufacturing Practices regulations. Excellent verbal and written communication skills. Comprehensive knowledge and understanding of regulatory laws, practices and/or procedures related to science and technology. Have been directing the district’s Compliance Branch for approximately two (2) years, as team leader and the director. Expertise includes:
► Reviewing and evaluating analytical data and evidence to determine compliance; ► Collaborating/interacting with various levels of staff and other officials involved in regulatory review matters; ► Providing advice/guidance on regulatory concerns to industry’s top management representatives; ► Recommending changes when compliance is in question; ► Ensuring compliance when violations are identified; ► Fully bilingual in English and Spanish. ► Certified in Level I requirements for human drugs Certification Program. ► Extensively participated in all phases of program management, sharing responsibility for mission accomplishment, assuming a positive role in managing the Field Office’s substantive enforcement programs. ► Routinely making substantive decisions and/or recommendations on controversial enforcement cases, using background knowledge of science and of the laws and regulations of the agency, and experience in regulatory activities.
► Bachelors Degree in Sciences, Major in Pre-Medicine, Minor in Physics – May, 1973 Total Semester Hours 146 --- 16 in chemistry, 18 in Biology, 15 in Mathematics, 26 in Physics and 4 in Human Physiology University of Puerto Rico, Rio Piedras Campus, Rio Piedras, PR.
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