The pharmaceutical, biotechnology, and medical device research and development industries are among the most regulated in the world. AAPS regulatory affairs program provides a comprehensive background and training required of regulatory affairs professionals to address domestic and international regulatory statutes and laws. The AAPS Regulatory Affairs program includes courses on; International, Health Canada, and FDA's laws, regulations, and Guidelines, investigational and marketing applications, technical writing, negotiation skills, development of New Drug Application (NDA) submissions, labeling and drug Information, Common Technical Documents (CTD), Notice of Compliance (NOC), Good Clinical Practices (GCPs), requirements for ongoing post-marketing surveillance and post-marketing changes, communication and management skills essential for the successful regulatory affairs professional in an industry work environment.
AAPS graduates from Regulatory Affairs program can pursue careers in the areas of Regulatory Affairs and Quality Operations in pharmaceutical, biotechnological and allied industries. Graduates will find employment as Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Administrators and Medical Information Associates.
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