Posted by regoverlord in 
I was recently asked what basic Legal & Regulatory Competencies that Regulatory Affairs Professionals must master. Thanks to notes from my Food, Drug & Medical Device Law class, the following offers a glimpse.
• Understanding of governmental structure & Constitutional boundaries
• An understanding of how federal law is enacted
• A thorough understanding of applicable enacted statutory law
1. Federal Administrative Procedures Act (FAPA)
2. Food, Drug & Cosmetic Act (as amended)
3. Public Health Service Act
4. United States Code (U.S.C.) of Statutory Law
• A thorough understanding of relevant Case Law
• Judicial Opinions that shape the powers of:
1. Branches of government (Executive, Legislative, Judicial)
2. Regulatory agencies,
3. Industry
• A thorough understanding of Rules & Regulations, Agency policies & procedures: Title 21 Code of Federal Regulations, among others
