Regulatory and Start Up Specialist
August 6
Description
• The Regulatory and Start Up Specialist is an experienced professional in regulatory and site start-up activities. • Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines.
Requirements
• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. • 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. • Strong communication and organizational skills are essential. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English and for non-English speaking countries the local language of country where position based.
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation
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