The Publishing Specialist will be responsible for supporting the end-to-end publishing and submission of regulatory dossiers for new and existing products in electronic format to meet company standards, agency requirements and defined timelines.

Description

· Publish Marketing (MA) Applications and maintenance submissions in eCTD or non-eCTD formats, as appropriate, for both new and existing products, including Emerging and Rest of World markets;

· Ensure all publishing requests are processed in a timely manner to meet internal and Health Authority deadlines and Service Level Agreements;

· Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to Regulatory Affairs and other disciplines as applicable for internal review/approval;

· Perform electronic transmission of submissions to Health Authorities as requested or provide finalised submission to country offices for local dispatch to Health Authorities;

· Archive submissions within the agreed timelines to ensure effective sharing with all internal stakeholders;

· Troubleshoot and resolve technical validation issues identified by regulatory agencies or during internal checks;

· Manage and monitor publishing schedules, coordinate global support during resource constraints, and provide workload and project summaries at team meetings or to leadership;

· Serve as the primary contact and Subject Matter Expert (SME) for publishing queries across Regulatory Affairs and cross-functional disciplines;

· Develop and maintain subject matter expertise in a designated area, act as the primary contact for related queries, and present updates on projects at team meetings;

· Attend and actively contribute to all Team and one-to-one meetings, including hosting Team Meetings on a rota basis, collating agenda items and preparing minutes;

· Document and share all learnings with the global Publishing team for the benefit of all regional teams;

· Develop high-quality working relationships and display social and business maturity when interacting with colleagues

Profile

· Academic qualification and a minimum of 3 years of professional experience. However, an equivalent combination of experience and/or education will also be considered;

· Experience with eCTD publishing tools (Lorenz docuBridge is preferred) and Document Management Systems (D2 and Veeva are preferred);

· Ability to manage and plan workload under competing priorities and tight timelines;

· Ability to work in a fast paced, highly cross functional team environment;

· Must maintain a strong knowledge of eCTD requirements for multiple Health Authorities;

· Ability to read and interpret complex business and/or technical documents;

· Strong organization skills and attention to detail.

Job Offer

The company offers a competitive compensation and benefits package, as well as the opportunity to work in a collaborative, international, and cross-functional environment that values diversity, inclusion, and professional growth.