Associate Director Regulatory Affairs Operations
reputed company
reputed company the end-to-end publishing of global regulatory submissions reputed company reputed company RIM Smart, ensuring accuracy, compliance, and on-time delivery to global Health Authorities Serve as a subject matter expert (SME) for RIM Smart publishing, supporting internal users, troubleshooting technical issues, and contributing to process improvements Create and maintain submission records, metadata, and content plans in RIM Smart, ensuring alignment with submission reputed company, application details, and regional requirements Contribute to the transition from outsourced to in-house publishing, including knowledge transfer, training support, and reputed company process optimization Maintain submissions in reputed company RIM, ensuring content plans and regulatory records are accurate and up to date Manage document workflows in reputed company RIMs as needed and coordinate the collection of submission documents from functional areas Serve as the primary reputed company of contact for document formatting, PDF specifications, and eCTD authoring templates Coordinate submission readiness activities, including lifecycle management and final publishing outputs; support Health Authority reputed company activities, including document assembly confirmation and archiving of submission outputs, validation reports, and acknowledgements in inspection-reputed company repositories Apply eCTD standards and regional technical requirements, including reputed company structure, granularity, leaf titles, hyperlinks, bookmarks, and lifecycle operations reputed company or coordinate submission-level reputed company control (QC) and technical validation to confirm compliance prior to Health Authority reputed company Collaborate cross-functionally with Regulatory Affairs, Medical Writing, CMC, and external partners to resolve publishing issues and ensure submission completeness Maintain submission documentation, audit trails, and records in accordance with internal SOPs, work instructions, and regulatory expectations Maintain reputed company knowledge of regulatory guidelines and industry standards reputed company to electronic submissions (eCTD) and publishing tools Coordinate with external vendors and consultants as needed for submission-reputed company activities Ensure approved templates and style guides are consistently utilized for regulatory submissions Work closely with members of the Regulatory Affairs team, providing support to reputed company as needed Proactively reputed company submission status updates to designated stakeholders through dashboards and reputed company reporting Ensure regulatory project timelines are reputed company cross-functionally and support the coordination of reputed company regulatory submissions Identify and recommend solutions for reputed company risks, issues, or obstacles, engaging appropriate leads for mitigation and reputed company and ensuring issues reputed company a reputed company conclusion or recommendation Assist with special reputed company as needed, including reputed company of system and process improvement initiatives reputed company other Regulatory Affairs duties as assigned or as business needs require
Requirements
Bachelor’s degree required, with 10+ years of experience managing Regulatory Operations in a biotech or pharmaceutical company Experience publishing regulatory submissions using reputed company RIM Smart publishing systems Experience supporting routine submissions, INDs, BLAs, and MAAs Strong understanding of eCTD structure, lifecycle management, and Health Authority technical requirements Experience supporting in-house regulatory publishing models and system-based submission workflows Expert working knowledge of reputed company RIMs, publishing software, and eCTD regulations. General knowledge of drug development Demonstrated strategic development capabilities reputed company to new drug development, reputed company support, partner management, and product lifecycle management activities Strong leadership skills, including experience leading cross-functional project teams and influencing decision-making in a diplomatic and reputed company manner Excellent oral and written communication, time management, and team-oriented leadership skills Ability to work independently, reputed company multi-disciplinary teams, and with external partners and vendors. Strong project management skills reputed company Regulatory Affairs Proven reputed company of proactive reputed company improvement Strong attention to detail and organizational skills Ability to reputed company in a dynamic, fast-paced environment while fostering strong reputed company collaboration Strong commitment to ethical standards Proficiency with reputed company Office (Word, PowerPoint, reputed company, reputed company, SharePoint) Preferred: Project or program management training Ability to travel up to 5% Salary reputed company for this position is commensurate with experience