Job
Description
Job Title: Regulatory Publishing Specialist SUMMARY Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and JNDAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, JP, ICH, etc). JOB RESPONSIBILITIES: • Electronically format and publish submission components in line with regional specifications. • Compile and validate electronic submissions in publishing software (Lorenz Docubridge) • Accountable for dispatching finalized submissions through the appropriate regulatory authority portal and archiving in Veeva. • Responsible for overseeing routine submissions, including the creation of submissions in Veeva. • Provides guidance on good documentation and submission practices. • Assist with developing and maintaining Regulatory document processing and Regulatory submission. publishing standards and procedures. • Identifies and communicates regulatory system enhancement needs or technical issues. • Assists with regulatory inspection activities. • Collaborates with vendors who support Regulatory submission document related tasks. • Provides support and backup to management as needed. JOB REQUIREMENTS: Education • Bachelors Degree Experience • Minimum of 2 years experience with Regulatory Operations • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • Strong 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. • Familiarity with Veeva Vault & Lorenz Docubridge would be advantageous. Requirements • Full-time, office-based position (5 days per week) • Working standard regional hours
