Regulatory affairs specialist with a talent for strong attention to detail and strategic thinker. Strong knowledge of regulatory affairs and health policies, Financial management technician and pharmaceutical science. Communicative and team-oriented with proficiency in all aspect of my work. Proven history of fostering army government funds to meet team, individual and management objectives.
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Regulatory affairs personnel is the first-line assurance the company products and documentation in accordance with regulatory bodies worldwide. The Professional Program in Regulatory Affairs, I have learned to reviews FDA regulations and other guidelines, Good Pharmaceutical Practice (GXP), Medical device and Biologic's principles and ethical considerations covering the development of drugs and dossiers for clinical trials, licensure and provides the training to manage these activities.
Additional coursework draws from the related functional areas of clinical research, product and process development, manufacturing and supply chain, pharmacovigilance and quality and compliance. Many required courses apply to multiple programs, allowing you to earn credit.
The Bachelor of Pharmaceutical Sciences was a four-year degree program that begins with a foundation of coursework in mathematics and the basic sciences -- chemistry, biology, and physics. This interdisciplinary program then progresses to advanced coursework in pharmaceutical sciences, including aspects of drug design and synthesis, mechanisms of drug action, pharmacology and toxicology, dosage formulation, manufacturing, quality assurance, and regulatory compliance.
The four-year program trained me for diverse positions in industrial, academic, or other research environments within the areas of drug discovery, development, and commercialization. It also prepares me for professional or graduates studies in graduate education in pharmaceutical, medical, and basic sciences and post-baccalaureate professional education in medicine, law, and business.
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