Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
Develop global regulatory CMC strategies to ensure acceptance rapid review and approval of marketing applications supplements/variations clinical trial applications and other submissions which include CMC information
Write and compile CMC sections of regulatory submissions including clinical trial applications and variations/supplements as well as registration submissions worldwide
Lead team of SMEs through extensive knowledge of eCTD requirements for Quality modules with respect to marketing authorization post approval changes and clinical trial applications globally
Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to understand regulatory impact of the risks identified to aid with mitigation and informed decision making
Manage answers to questions from the Health Authorities in a timely and effective manner to ensure early approval
Interact and negotiate with Health Authorities on CMC issues
Develop and maintain project plans and schedules for CMC submissions
Evaluate proposed manufacturing changes for global impact assessments and provide regulatory strategies that support change implementation
Provide guidance on ICH FDA and EU CMC guidelines
Develop and maintain strong relationships with internal functional groups contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives
Represent the Regulatory Affairs CMC function on assigned crossfunctional project teams
Ensure all CMC dossiers and relevant regulatory information are stored in Veeva according to Clients guidelines
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Manager
Employment Type
Full-Time
