To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
• Prepares, review and completes regulatory submissions for INDs, MAAs, CTAs, NDAs, IDEs, ITAs, DSURs and annual reports including post marketing activities to FDA, Health Canada and other regulatory authorities.
• Collaborates with sponsor, study start up, clinical and regulatory staff to ensure that all regulatory documents required for site IP approval are collected and reviewed in a timely fashion.
• Prepares and submits serious adverse events (SAEs) and Safety Reports, Medical Device Report (MDR), Development Safety Update Report (DSUR), Clinical Evaluation Report (CER) Clinical Study Reports (CSR), Unanticipated Adverse Devise Effects Reports (UADEs).
• Provides update and communicate with sponsor, project manager, study start up and clinical team to anticipate, identify and resolve issues.
• Assists Associate Director and Director, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
• Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Identifies essential regulatory documents required for execution of both domestic and global clinical research studies involving drugs, device and combination products.
• Reviews protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
• Ensures the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
• Provides regulatory guidance and quality assurance assessments for assigned research projects - domestic and international.
• Develops training modules and presentations to ensure compliance with applicable regulatory regulations, CFR, FDA/ICH guidelines, GCP, Essential Regulatory Documents and project specifications.
• Creates SOPs, Work Instructions, and procedures for Regulatory Operations, as needed
• Serves as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
• Serves as IQVIA Biotech liaison with central IRBs.
• Serves as a mentor for coworkers and train others on tasks or systems.
• Performs other related duties as assigned.
• Senior Specialist level would be minimum 5-7 years North American (US required; and Canada preferred) regulatory submissions experience while Specialist would be 3-5 minimum years; 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 5 years of related work experience, science degree preferred or equivalent level of education and work experience.
• Five 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 prioritise workload with minimal supervision
• Ability to propose revisions to SOPs or suggest process improvements for consideration
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.
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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 firstname.lastname@example.org to arrange for such an accommodation.