Course Title: Regulatory Affairs Associate
Course no:108
Credit Hours: 730 Hours
Program Length:
Morning and afternoon classes, 25 hrs. Per week (30 weeks). Night classes, 20 hrs. Per week (37 weeks).
Prerequisites:
Be at least 18 years of age. The student must have at least two years of college or associate degree or equivalent degree to enroll for this program. In addition, you need to pass the BioHealth College entrance exam.
Course Objectives:
The Pharmaceutical and Biotechnology Regulatory Affairs Associate curriculum prepares the students to work in the bioscience industry in the areas of research and development, Drug business development, Clinical and regulatory affairs as well as different entry level management areas. Potential employers include biotechnology and pharmaceutical companies, as well as clinical laboratories in hospitals, universities, government and independent settings. As the biotechnology industry expands more people will be needed to train new workers and manage bioscience facilities.
Catalog Description:
This program allows students to acquire the necessary knowledge to enter the pharmaceutical and biotechnology industry as an entry level regulatory affair associate.
The student will learn to assist the regulatory affairs team of pharmaceutical and biotechnology companies in cross-functional team activities from initial stages through securing FDA approval, apply scientific principles to understanding safety and efficacy on a wide range of products. Assist in participation on product development teams to insure US and other international regulatory requirements. She/he will learn to understand and assist in post market submissions (progress reports, annual reports etc.), support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers, and understand and apply regulatory forms. She/he learns to establish and maintain regulatory information systems both electronically and hard copy, and interpret existing and/or new regulatory requirements as they relate to company products and procedures.
Course Outline: Biotechnology Business Management
Introduction to Basic Science & Computer Skills
Introduction to Cell and Molecular Biology
Foundation of Biotechnology and Genetic Engineering
Principles of Business Management
Biotechnology Laboratory Fundamentals
Regulatory Affairs I
Regulatory Affairs II
Career Development / Job prep
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