Masters or foreign equivalent degree in a Biomedical Engineering, BioInformatics, Pharmacy, Pharmacology, Regulatory AffairsScience or in a related scientific or technical field of study Will accept a Bachelors degree in the above fields 5 years of related progressive experience in lieu of a Masters degree each alternative requirement with at least 1 year of experience in i utilizing knowledge and experience in the pharmaceutical andor medical device industry in preparing and submitting international product registrations and licensing applications original submission and subsequent product enhancements; ii understanding, investigating and evaluating regulatory historybackground of class, disease therapeuticdiagnostic context in order to assess regulatory implications for approval, and determine trade issues to anticipate regulatory obstacles; and iii providing regulatory representation and support for product review, product change, and product transfer through product lifecycle. Employer will accept any suitable combination of education, training, or experience.
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