Global Publishing Manager, Regulatory Affairs

The Role

The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory Lead, you will manage and prepare high-quality global submissions, both in-house and via CROs, ensuring timely delivery of compliant submissions to global health authorities. The Global Publishing Manager provides regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence in the planning, preparation, and delivery of regulatory submissions. You will act as the primary point of contact for daily submissions for major submissions and lead a team of publishing specialists. At Moderna, we act with urgency and behave like owners, reflecting our commitment to delivering transformative medicines to patients.

Here’s What You’ll Do:

• Compile, publish, and verify submission dossiers in accordance with international eCTD requirements.

• Act as a team leader, providing direction, support, and mentorship to the publishing team.

• Oversee the compilation, publishing, and verification of submission dossiers in accordance with international eCTD requirements and regulatory guidelines.

• Lead and manage the submission of MAA, INDs, NDAs, BLAs, Master Files, and other regulatory documents.

• Work closely with team members to compile documents, review hypertext links, ensure PDFs are submission ready, format tables and graphics, bookmark sections, and proof submissions according to internal standards.

• Develop and implement new processes and procedures to enhance efficiency and accuracy during the submission process.

• Collaborate with submissions management to build technically valid and high-quality dossiers.

• Manage the submission of eCTD sequences through health authority gateways.

• Perform quality control (QC) of documents published by team members to ensure compliance with applicable guidance documents.

• Assist with the remediation of Word documents to ensure proper format and compliance.

• Mentor and train team members to increase the quality across the team.

• Participate in internal and external audits, maintaining compliance with department systems, e.g., project database, timesheets, training.

• Contribute to the development of new publishing services and actively participate in department initiatives and process improvements.

• Maintain a strong understanding of applicable regulatory guidelines and ensure the achievement of individual and team utilization targets.

• Act as the primary point of contact for the team, providing regular updates to senior management on project status and any issues affecting quality, timelines, and adherence to contractual obligations.

Here’s What You’ll Bring to the Table:

• Bachelor’s degree or equivalent.

• At least 5 years of experience as a regulatory Publisher in a pharmaceutical company or CRO, with 2+ years in a management role.

• Experience leading the submission of MAA, INDs, NDAs, BLAs, Master Files, etc., formatted according to international eCTD requirements.

• Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.

• Experience with electronic clinical document publishing standards/formats and global regulatory submission publishing standards/formats (e.g., eCTD, EU CTR).

• Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools.

• Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA).

• Strong interpersonal and project management skills, with experience working in a complex, global cross-functional organization.

• Highly motivated, organized, and detail-oriented team player.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

• Ability to readily adjust to change in a fast-paced environment and multitask.

• Positive attitude and ability to effectively collaborate with peers, stakeholders, an