Regulatory Affairs Manager - Clinical trials
Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline, works independently under limited supervision. Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.
- Acts as a Regulatory Advisor on complex clinical trial projects or programs
- Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
- Prepares and maintains core clinical trial dossiers in accordance with applicable regulatory requirements.
- Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, Investigator’s Brochure, clinical trial justifications with minimum support of senior staff
- Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical trials.
- May strategically plan and oversee global country submissions
- Can provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
- Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
- Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
- Deliver regulatory training/presentations as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good understanding of the regulations, directives and guidance supporting clinical Research and Development
- Demonstrates comprehensive regulatory/technical expertise
- Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
- Strong ownership and oversight skills
- Demonstrated skills in chairing small meetings
- Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision
- Ability to propose revisions to SOPs or suggest process improvements for consideration
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Strong software and computer skills, including MS Office applications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience)
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Travel will be required
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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