Throughout biomedical product development, production and commercialization, regulatory affairs professionals play critical roles in ensuring their companies' compliance with the laws and regulations. In addition to a strong working knowledge of the regulations and solid ethical grounding, strong business and leadership skills are vital to the success of a regulatory professional.
This seminar-format course addresses important competencies for RA professionals, including effective negotiation and communication, the conduct of regulatory research, and approaches to educating and motivating senior management and staff about compliance. Through discussions, real-world examples and case studies, senior regulatory professionals help students learn about regulatory strategy, how to work in the regulatory "gray zones," and the important legal and ethical responsibilities of regulatory affairs personnel.
This course should be taken toward the end of the Regulatory Affairs Certificate Program curriculum.
