Frances J Richmond1, Terry D Church2. 1. Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, 1540 Alcazar Street, CHP 140, Los Angeles, CA, 90089, USA. fjr@usc.edu. 2. Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, 1540 Alcazar Street, CHP 140, Los Angeles, CA, 90089, USA.
Abstract
BACKGROUND: Talent acquisition in regulatory affairs has been a continuing challenge now exaggerated by demographic shifts and expansion of regulatory requirements nationally and globally. METHODS: Survey and interview methods were used to provide information on graduation rates, graduate characteristics, and enrollment trends in the 17 US regulatory programs that could be identified to offer graduate degrees in regulatory affairs or regulatory science. RESULTS: US programs graduated approximately 522 MS and 4 doctoral students in 2018. About 70% of students attended programs in the Northeast; the remaining students were evenly split between programs in the Northwest and Southeast/Southwest. About half of the programs provided content by distance only. About 127 students were new entrants to the workforce; enrollments for this group most commonly leveled or decreased over the last 3 years. The primary challenge identified by most programs was the high tuition that discouraged participation by qualified candidates for the programs. Challenges were also reported when attracting international students because of tightening visa restrictions and consequent reluctance of industry to hire students with a temporary visa status. CONCLUSIONS: The small number of graduating regulatory professionals from US universities is alarming because it falls far short of needs estimates for positions in regulatory departments. The particularly low number of entry-level professionals seems unlikely to be adequate as unemployment rates tighten and experienced professionals become harder to attract. These shortfalls may be particularly hurtful to small companies unable to compete for experienced professionals.
BACKGROUND: Talent acquisition in regulatory affairs has been a continuing challenge now exaggerated by demographic shifts and expansion of regulatory requirements nationally and globally. METHODS: Survey and interview methods were used to provide information on graduation rates, graduate characteristics, and enrollment trends in the 17 US regulatory programs that could be identified to offer graduate degrees in regulatory affairs or regulatory science. RESULTS: US programs graduated approximately 522 MS and 4 doctoral students in 2018. About 70% of students attended programs in the Northeast; the remaining students were evenly split between programs in the Northwest and Southeast/Southwest. About half of the programs provided content by distance only. About 127 students were new entrants to the workforce; enrollments for this group most commonly leveled or decreased over the last 3 years. The primary challenge identified by most programs was the high tuition that discouraged participation by qualified candidates for the programs. Challenges were also reported when attracting international students because of tightening visa restrictions and consequent reluctance of industry to hire students with a temporary visa status. CONCLUSIONS: The small number of graduating regulatory professionals from US universities is alarming because it falls far short of needs estimates for positions in regulatory departments. The particularly low number of entry-level professionals seems unlikely to be adequate as unemployment rates tighten and experienced professionals become harder to attract. These shortfalls may be particularly hurtful to small companies unable to compete for experienced professionals.
Keywords:
drugs; master's degrees; medical devices; recruitment; skills
Authors: Andrew O Brightman; R Lane Coffee; Kara Garcia; Aaron E Lottes; Thomas G Sors; Sharon M Moe; George R Wodicka Journal: J Clin Transl Sci Date: 2021-01-19
Authors: Aaron E Lottes; Kenneth J Cavanaugh; Yvonne Yu-Feng Chan; Vincent J Devlin; Craig J Goergen; Ronald Jean; Jacqueline C Linnes; Misti Malone; Raquel Peat; David G Reuter; Kay Taylor; George R Wodicka Journal: J Cardiovasc Transl Res Date: 2022-03-14 Impact factor: 3.216