Head of International Regulatory Affairs
vor 3 Monaten
Requirements:
Master’s degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences; At least 15+ years of pharmaceutical industry experience inclusive of 10 years of global Regulatory Affairs experience or a combination of 8+ years of global Regulatory Affairs and related experience; Demonstrated recent successful Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the EU and international countries. Rare disease and pediatric drug development experience is highly desirable; Strong working knowledge regarding the selection, development, and evaluation of Clinical Outcome Assessments (COAs); Candidates must have proven strategic development capabilities related to new drug development, commercial support, partner management, as well as product lifecycle management activities (including relevant interactions with international Business Partners/CROs); An extensive background and excellent relationship in working with the EU EMA and/or other regulatory agencies; broad experience in global drug development; Regulatory strategic and operational support to implement global Managed Access Programs; Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies; Strong oral and written communication, time management, and team-oriented leadership skills are essential; Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.-
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