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Biogen Manager, Regulatory Affairs in Cambridge, Massachusetts

  • Responsible for coordinating the regulatory clinical trial applications (CTA) submission activities for assigned clinical trials. * Experience in global regulatory CTA submission regulations, requirements and will be responsible for the global CTA submission strategy, as well as managing Contract Research Organization. Responsibilities * The Regulatory Clinical Trial Application Lead will represent Regulatory Affairs in the study management teams. This will include providing regulatory strategy and overseeing activities conducted by the contract Research Organization * Will facilitate the gathering of or author documents to be included in the clinical trial application * The Regulatory Clinical Trial Application Lead role will be the primary contact point between Regulatory and the CRO for the management of submissions of CTAs. * The Regulatory Clinical Trial Application Lead will ensure that the submission and approval events are tracked. * Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required * Proven experience in preparing and making clinical trial applications outside of the U.S. * Familiar with the Clinical Trial Directive in the European Union * Knowledgeable with scientific terminology. * Ideal candidate would possess proven experience within regulatory affairs in the pharmaceutical industry. * An understanding of drug development, clinical trial authorization applications, Regulatory Affairs, and associated regional and national requirements for conducting Rest of World clinical Trials * Must have strong communication skills (written and verbal) * Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency). * Ability to lead complex projects and a high degree of problem solving capability required. * Must be able to work independently, strong initiative All your information will be kept confidential according to EEO guidelines.
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