• 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 Sobi’s guidelines