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 cross-functional project teams •  Ensure all CMC dossiers and relevant regulatory information are stored in Veeva according to Client’s 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 https://jobs.iqvia.com IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled