Director Level Overview
The director level is a senior position with a high level of involvement in, and management of, regulatory functions throughout the product lifecycle, as well as active involvement in management functions. In many organizations, the director reports to a vice president managing regulatory functions. Associate directors may report to a director or vice president.
The majority of directors have graduate experience, one or more RAC designations and/or degrees in the clinical or life sciences or engineering. Some hold an MBA degree. Professionals at this level have an average of 22 years of professional experience and nearly 13 years of regulatory experience.
Vice President Level Overview
The title of vice president represents a senior position in all employment settings, typically encompassing a combination of executive management, regulatory and technological responsibilities. The majority are employed in industry, working for organizations of all sizes Professionals at this level have extensive professional experience, including an average of nearly 18 years in the regulatory profession. Close to half hold the RAC designation, and the majority have graduate experience and/or advanced degrees. In addition, they hold degrees in life and/or clinical sciences or engineering.
CEO/President Level Overview
The majority of respondents with the title of CEO/president are highly-experienced, well-educated regulatory professionals employed in small-sized consulting firms, with a small portion employed in industry, CROs or research organizations. They have 15 or more years of regulatory experience and an average of 30 total years of professional experience. In addition, they have graduate training and/or a graduate degree. At the CEO/president level, approximately 26-30% of their time is related to pre- and postmarket-related activities, respectively. Nearly 38% of time is directed to business-related functions and regulatory strategy. The level of involvement in these areas indicated that the majority of respondents both supervise and perform specific activities, which may reflect the consulting setting among this group.