Assistant Regulatory Ectd Publishing Manager

PURPOSE AND SCOPE Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned Maintains systems designed to ensure compliance with electronic submission requirements and document management systems In addition to publishing responsibilities this role will lead and support the creation implementation and ongoing maintenance of departmental Standard Operating Procedures SOPs Work Instructions WIs and operational processes ensuring alignment with evolving regulatory requirements internal standards and best practices PRINCIPAL DUTIES AND RESPONSIBILITIES Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes applies creative problem-solving to resolve a wide range of technical and operational issues Manages the end-to-end preparation compilation publishing quality control validation and delivery of electronic regulatory submissions eCTD in compliance with global Health Authority requirements and internal standards Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions e g supplements variations renewals across multiple regions including the U S Canada EU and Asia-Pacific Performs thorough QC reviews to ensure submission-ready documents meet formatting technical and regulatory standards Collaborates cross-functionally with Regulatory Affairs CMC Medical Writing Quality and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions Interprets and applies key regulatory guidance regional submission specifications and evolving eCTD requirements including ICH FDA EMA etc Leads and contributes to the development revision implementation and training of departmental SOPs WIs and standardized publishing processes to ensure consistency efficiency and regulatory compliance Assists in the management and continuous improvement of templates procedures and tools used to support global submission activities Troubleshoots technical issues related to publishing tools and document formatting particularly within MS Word and Adobe Acrobat and supports resolution of validation errors Participates in evaluating and implementing new regulatory technologies ensures alignment with infrastructure standards and supports transitions from legacy systems to electronic platforms Maintains compliant archival and storage of regulatory documents ensuring alignment with regulatory and business needs May mentor junior staff provide publishing guidance and act as a resource for complex submissions Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines Ensures compliance with all applicable regulations company policies and the Code of Business Conduct May escalate complex issues for resolution and assist with additional projects or duties as assigned Assist with various projects as assigned by a direct supervisor Other duties as assigned Additional responsibilities may include focus on one or more departments or locations See applicable addendum for department or location specific functions PHYSICAL DEMANDS AND WORKING CONDITIONS The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function EXPERIENCE AND REQUIRED SKILLS Bachelor s Degree required Advanced Degree desirable Minimum five 5 years of regulatory operations experience in the pharmaceutical or biotechnology industry with a strong emphasis on global regulatory submissions Proven expertise in the preparation compilation publishing and validation of eCTD submissions in support of U S FDA Canada Health Canada EU EMA MHRA and Asia-Pacific PMDA TGA NMPA etc regulatory requirements In-depth knowledge of electronic publishing tools and Regulatory Information Management RIM systems Proficiency with electronic document management systems EDMS and advanced knowledge of document formatting tools particularly MS Word template and style management and Adobe Acrobat PDF optimization and troubleshooting Strong understanding of global regulatory submission guidance Demonstrated experience managing multiple submission projects in parallel with proven ability to meet tight deadlines and deliver high-quality technically compliant outputs Strong organizational skills and meticulous attention to detail able to identify and resolve issues independently and proactively Excellent written and verbal communication skills with the ability to clearly document processes communicate submission requirements and collaborate effectively across teams Experience with electronic submissions specifically eCTD required Strong understanding of document management processes in a regulated pharmaceutical environment Demonstrated understanding of the drug development process and project management experience is highly preferred Proven experience in developing revising and maintaining departmental Standard Operating Procedures SOPs Work Instructions WIs and internal processes with a focus on continuous improvement and regulatory compliance Strong software troubleshooting skills If your location allows for pay benefit transparency please click the link below to request further information on this position