Manager, Regulatory Operations (Publishing)

Replimune•Woburn, MA

7d•Hybrid

About The Position

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. We are seeking an experienced Senior Manager, Global Regulatory Submission Management and Publishing to lead the planning, preparation, publishing, quality control, and submission of global regulatory dossiers. This role is a key member of the Regulatory Operations team and will partner closely with Regulatory Affairs, Medical Writing, Clinical Operations, Biostatistics, Data Management, Quality, and external service providers to ensure the successful delivery of high-quality, compliant submissions to global health authorities. The successful candidate will possess extensive expertise in regulatory submission management, eCTD publishing, and global regulatory requirements. This individual will provide technical leadership across submission programs, mentor team members, drive operational excellence, and contribute to the development and continuous improvement of submission processes, standards, and technologies. This position is based in our Woburn office and welcomes remote work, with an expectation of approximately 10% onsite attendance (e.g., annual company-wide meetings and key business events).

Requirements

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

Nice To Haves

Experience with StartingPoint tools and templates preferred.
Experience with Veeva PromoMats is preferred.

Responsibilities

Lead the planning, coordination, preparation, publishing, validation, and submission of global regulatory dossiers.
Partner with Regulatory Operations Leads and Regulatory Strategy Leads to ensure the timely delivery of compliant submissions to global health authorities.
Serve as the Regulatory Operations lead and primary point of contact for assigned submission programs and major regulatory milestones.
Provide regulatory operations expertise to cross-functional teams throughout submission planning, preparation, execution, and archiving activities.
Manage submission timelines, deliverables, risks, and communication with internal stakeholders and external vendors.
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.