$200K — $250K *
Director, CMC Regulatory Project Management, under direction of the Head of CMC Regulatory Affairs, will work effectively with product development teams to establish and manage timelines and deliverables in support of global CMC regulatory submissions, CMC development activities, and responses to health authorities. . This individual will coordinate submissions using Veeva Vault RIM, establish submission timelines and track progress for submission deliverables, coordinate/ support cross-functional submission planning meetings, and collaborate closely with Regulatory Operations for submission execution, while actively contributing to the overall project team. In addition, this individual will serve as the primary regulatory liaison for external manufacturing organizations.
Director, CMC Regulatory Project Management will play a key role in establishing and tracking timelines and implementing planned regulatory strategies and requirements into practical, workable deliverables to support development and commercial stage drugs.
• BA in Science or related field with at least 10 – 12 years’ experience in Biotech Pharmaceutical Industry
• Strong organizational and communication skill set.
• Proven track record of successful on-time submissions.
• Experience working with external partner companies and vendors
• CMC technical background
• Regulatory knowledge of submission requirements, content and format for submissions to Global health authorities.
• Common Technical Document (CTD) structure, electronic (eCTD) submission requirements, and electronic document management system (First Doc, Veeva)
• Regulations, guidance, and procedures applicable to FDA and EMA for Biotech products.
• Microsoft® Office 365 suite, with experience in MS Project and MS OneNote applications
• Knowledge of Veeva Vault RIM (preferred not required)
Valid through: 10/21/2020