Job Description
Responsible for managing Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Job Duties
• Manages staff who electronically format, publish electronic documents and builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
• Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
• Provides guidance on good documentation and submission practices
• Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications.
• Identifies regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions
• Assists with regulatory inspection activities
• Provide Document authoring template training.
• Maintains Authoring Template Library and works with cross-functional teams to develop and maintain templates
• Collaborates with vendors who support Regulatory operations related tasks.
• Communicates the need for additional resources to management as needed.
• Requires to function as a contributor as needed.
• Provides support and backup to management as needed.
Job Requirements
• Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
• Working knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required.
