IQVIA Reg Affairs Manager - Non-Clinical in Bangalore, India
• Involve in a variety of projects of diverse scope and complexity, across all developmental stages (pre-development through post-marketing) and major therapeutic areas.
• Author or review nonclinical sections of regulatory documents, such as Investigator's Brochures (IBs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs).
• Analyze, interpret, and distill nonclinical data to independently write and/or edit nonclinical documents. Ensure alignment with International Conference on Harmonization (ICH) guidelines, regulatory requirements, and processes.
• Author or review nonclinical technical reports. Summarize pharmacology, pharmacokinetics and toxicology data and prepare briefing packages for regulatory agency meetings or advice.
• Apply advanced knowledge of relevant regulatory requirements, as well as work experience, to assess document requirements and identify information gaps or other potential issues.
• Contribute to or prepare responses to requests for nonclinical information to worldwide health authorities.
• Responsible for the planning and management of nonclinical regulatory submission components for compounds in Development portfolio.
• Represent regulatory writing team (Clinical/Non-Clinical) on cross-functional teams, and will lead the sub-teams, working in close partnership with stakeholders
• Provide regulatory writing (Clinical & non-clinical) expertise and mentorship to team members.
• May lead or support training initiatives within the group and will support maintenance of a balanced workload among nonclinical and clinical writers.
• Lead the planning, tracking, compilation, and regulatory compliance of clinical & nonclinical documentation for regulatory submissions.
• Learn and understand new therapeutic areas quickly and comprehensively.
• Possess innovative problem-solving skills and ability to influence peers.
Master’s in veterinary medicine (MVSc)/Ph.D. in scientific field (e.g., biology, pharmacology, toxicology), with minimum of 4 years of experience with nonclinical and/or scientific/medical writing within pharmaceutical or Contract Research Organization (CRO).
Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process.
Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing books, INDs, periodic reports, NDAs/MAAs/BLAs, and agency responses.
Experience with regulatory submissions for new modalities (eg: cell therapies, gene therapies, microbiome) is an advantage.
Experience in a program management-type role; ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to regulatory submission aims.
Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements).
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 70,000+ 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 a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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