Regulatory Affairs Specialist - Start-up
Yesterday
Description
• The Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan. • Serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies. • Support the SSU/Regulatory Lead to project site-specific submission/approval timelines and ensure they are met.
Requirements
• Bachelor’s degree (BA/BS) in a science-related field preferred or equivalent combination of education, training and experience. • Experience working the pharmaceutical, biotechnology or CRO industry and knowledge of clinical trials process required. • Previous experience in Clinical Trial Regulatory submissions. • Excellent oral and written communication skills. • Excellent interpersonal and organizational skills with strong attention to detail. • Good customer/client relationship management and proactive problem-solving skills. • Knowledge of the principles, methods, and procedures of clinical research. • Good computer skills including MS Word, Excel, PowerPoint, Outlook. • Experience with ICH/GCP documentation and process preferred. • Ability to assess, coordinate, and organize/reorganize workload of multiple projects in accordance with project priorities/assignments and timelines with focus on execution.
Benefits
• Training and career development opportunities internally • Strong emphasis on personal and professional growth • Friendly, supportive working environment • Opportunity to work with colleagues based all over the world, with English as the company language
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