Director, Regulatory Affairs #AS-012-JP
Director, Regulatory Affairs - Allergan Sales LLC. (an AbbVie co.) in Orange County, CA seeks qualified Director Regulatory Affairs. Responsible for development of Global Regulatory Strategy & representation of regulatory affairs on R&D Project Teams. Must possess expertise/ knowledge sufficient to adequately perform the duties of the job being offered. Expertise/ knowledge may be gained through employment experience or education. Such expertise /knowledge cannot be "quantified" by "time".
Required expertise/knowledge includes: Developing global regulatory affairs strategy for pharmaceuticals /biologics/combination products; technical background evidenced by past performance as regulatory lead on global project teams & exp in leading registration submissions for complex pharmaceutical/biologics in multiple countries; project management skills, incl evidence of managing multiple complex development projects simultaneously; Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy; Ability to prepare complex documents/ submissions & to give presentations; Experience working in a matrixed environment; Leadership roles on global project teams; Neurotoxin product development or ophthalmology products. Indicate the major(s) and/or field(s) of study required & indicate the occupation(s) required: Bachelor of Science or foreign equivalent in Biological Sciences, Microbiology, Microbial Technology, or closely related scientific field plus twelve (12) years of experience in regulatory affairs or closely related occupation. In lieu of this, employer will accept a Ph.D. degree or foreign equivalent in Biological Sciences, Microbiology, Microbial Technology, or closely related scientific field plus eight (8) years of experience in regulatory affairs or closely related occupation OR a Master of Science or foreign equivalent in Biological Sciences, Microbiology, Microbial Technology, or closely related scientific field plus ten (10) years of experience in regulatory affairs or closely related occupation. Employer will accept any suit combination of education, training or experience related to the job opportunity. An EOE.