At least 4 years of experience managing multiple regulatory affairs subfunctions including Regulatory Labeling; Advertising and Promotion Compliance; Regulatory Intelligence, Science and Policy; Chemistry and Manufacturing Controls; Regional Regulatory Affairs; and Regulatory Operations; At least 4 years of experience working directly with the FDA and EMA as the Regulatory Lead of new drug applications, supplemental new drug applications and marketing authorization applications; At least 4 years of experience in regulatory affairs within the early and latephase of drug andor biologics product development; and At least 4 years of experience preparing and submitting regulatory documents including IND, CTA, NDA, and MAA.br br br Employer will accept Bachelors degree or foreign academic equivalent in Life or Regulatory Sciences or related and six 6 years of experience in a regulatory affairs role in the pharmaceutical or biologics industry.br br Employer will also accept a Masters degree or foreign academic equivalent in Life or Regulatory Sciences or related and four 4 years of experience in a regulatory affairs role in the pharmaceutical or biologics industry.br br Employer will accept any suitable combination of education, training and experience.
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