Senior Specialist, Regulatory Affairs - Start-up
4 days ago
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 sites. •Support SSU/Regulatory Lead to meet project timelines. •Prepare, collect, review regulatory information and documents for submissions to authorities. •Actively correspond with sites for updates regarding essential document completion. •Coordinate with study teams and sponsors on document priority and processing. •Participate in ICF development, review, negotiation and approval processes. •Ensure all relevant essential documents are submitted timely as defined by SOPs.
Requirements
•Bachelor’s degree (BA/BS) in a science-related field preferred or equivalent combination of education, training and experience. •Experience working in 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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