Job Posting for Regulatory Affairs Specialist (Contract, Home-Based) - IQVIA Biotech at IQVIA
Qualifications •Minimum 3 years North American (US required; and Canada preferred) regulatory submissions experience; including, but not limited to: briefing packages, response to FDA questions, pre-IND submissions, IND submissions, and IND maintenance activities, including DSURs. CMC and/or non-clinical writing of clinical trial applications/INDs experience is required, eCTD and ESG experienced preferred, knowledge of publishing process a plus. Experience in biologics, vaccines is a plus. NDA/BLA compilation experience a plus, but not required. Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies. Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents for pre-IND and IND submissions, with oversight from Regulatory Management. • Requires Bachelor's degree with at least 3 years of related work experience, science degree preferred or equivalent level of education and work experience. • Three or more years of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research. • Excellent analytical and communication skills, particularly writing skills, are essential. • Ability to travel a minimum of 20% both domestically and internationally is required. • Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach • Strong software and computer skills, including MS Office applications • Demonstrated skills in chairing small meetings • Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.