* 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience. Regulatory history, guidelines, policies, standards, practices, requirements and precedents Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial trade requirements, agreements and considerations Domestic and international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory process Regulatory history, guidelines, policies, standards, practices, requirements and precedents Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial trade requirements, agreements and considerations Domestic and international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory process Pay strong attention to detail Manage projects Create project plans and timelines Think analytically Organize and track complex information. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results Has broad knowledge of various technical alternatives and their potential impact on the business Exercise good and ethical judgment within policy and regulations Use in-depth knowledge of business functions and cross group dependencies/ relationships Define regulatory strategy with supervision Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.