Sr. Manager, Global Regulatory Publishing

Replimune's Mission

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. We imagine a world where cancer is a curable disease.

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With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

We are seeking an experienced in-house Senior Manager, Global Regulatory Publishing, who can prepare and submit a variety of submissions with high quality.

This role often involves working closely with regulatory affairs teams, medical writers, and other stakeholders to ensure that all necessary documentation is prepared and submitted to regulatory authorities.

In this position, you will participate in various activities as part of a dynamic and evolving Regulatory Operations team.

The Senior Manager, Global Regulatory Publishing must be independent, creative, resourceful, with excellent organization, written / verbal communication and attention to details.

This position is based in our Woburn office and welcomes remote work with the requirement to be on-site 10% (ex. annual company-wide meeting)

Responsibilities

• Overseeing the planning, creation, and submission of regulatory submissions
• In collaboration with the Regulatory Operations Lead(s) and Regulatory Strategy Lead(s), manage and prepare high-quality global submissions, both in house and via CROs, ensuring timely delivery of compliant submissions to global health authorities
• Work closely with regulatory affairs teams, medical writers, and other stakeholders to ensure that all necessary documentation is prepared and submitted to regulatory authorities
• Provide regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence in the planning, preparation, and delivery of regulatory submissions
• Primary point of contact for daily submissions for major submissions
• Using Veeva RIM to 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, CTIS, INDs, BLAs, 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 to ensure compliance with applicable guidance documents
• Assist with the remediation of Word documents to ensure proper format and compliance
• Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; and help implement associated process improvements
• Mentor and train team members to increase the quality across the team
• 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

Qualifications

Educational requirements :

Experience and skill requirements :