Sr. Manager, Regulatory Operations (Publishing)

· Compile, publish, validate, and transmit regulatory submissions in accordance with global health authority requirements and electronic submission standards.

· Lead publishing activities for INDs, BLAs, MAAs, CTIS submissions, amendments, supplements, annual reports, and other global regulatory submissions.

· Manage submission transmissions through applicable health authority gateways and portals.

· Ensure submission dossiers are technically valid and compliant with applicable regulatory guidance and organizational standards.

· Perform publication quality control and verification activities to support first-time-right submissions.

· Serve as a subject matter expert for Veeva Vault RIM Submissions and Publishing.

· Manage dossier planning, content planning, submission assembly, continuous publishing, validation, and submission activities within Veeva Vault RIM.

· Support system optimization, process improvements, and implementation of best practices related to regulatory submissions management and publishing.

· Develop, implement, and continuously improve processes, standards, templates, and procedures related to regulatory publishing and submission management.

· Monitor evolving global regulatory submission requirements and ensure organizational compliance with applicable regulations and guidance.

· Support inspection readiness activities and contribute to audit responses related to regulatory submissions and electronic records.

· Identify opportunities for automation and operational efficiencies within Regulatory Operations.

· Provide leadership, mentoring, and technical guidance to publishing and submission management team members.

· Support knowledge sharing and training initiatives to promote consistency, quality, and operational excellence.

· Collaborate effectively across global cross-functional teams and external partners to achieve project objectives.

· Contribute to departmental initiatives and strategic goals that enhance Regulatory Operations capabilities.

Educational Requirements

Bachelor's degree (BA/BS) or equivalent combination of education and relevant experience required.

Experience and Skill Requirements

· Minimum 8 years of Regulatory Operations and Regulatory Publishing experience within the biotechnology, pharmaceutical, or related industry.

· Demonstrated experience leading complex global regulatory submissions from planning through delivery.

· Strong knowledge of global regulatory requirements and health authority expectations, including FDA, EMA, MHRA, ICH, and other applicable regions.

· Extensive experience leading submissions such as INDs, BLAs, MAAs, CTIS submissions, amendments, supplements, and annual reports.

· Experience working with SEND datasets and regulatory submission datasets.

· Expert-level knowledge of Veeva Vault RIM Submissions and Veeva Vault RIM Publishing is required.

· Demonstrated hands-on experience preparing, publishing, validating, and transmitting submissions using Veeva Vault RIM.

· Experience with electronic submission standards and formats, including eCTD and CTIS.

· Knowledge of regulatory publishing tools such as DXC, eCTD Xpress, ISI Toolbox, Lorenz, or equivalent platforms.

· Experience with StartingPoint tools and templates preferred.

· Strong technical, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.

· Excellent project management, organizational, and stakeholder management skills.

· Demonstrated ability to consistently deliver high-quality, compliant submissions while meeting aggressive timelines.

· Strong written and verbal communication skills.

· Highly motivated, detail-oriented team player with a collaborative and positive approach.

· Experience with Veeva PromoMats is preferred.