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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United : We Collaborate for a Common Goal.

Audacious : We Are Bold and Innovative.

Dedicated : We Give Our Full Commitment.

Candid : We Are Honest With Each Other.

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we make it personal

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 :

BA or BS degree or equivalent experience required

Experience and skill requirements :

Minimum 5 years of experience as a regulatory Publisher in biotech / pharmaceutical industry required

Experience with Veeva Vault RIM publishing (e.g. xml bone build) is required. Experience with Veeva PromoMats preferred.

Strong experience with global Clinical and Regulatory Health Agency (HA) requirements (e.g., FDA, ICH, EMA, MHRA)

Experience leading the submission of MAA, CTIS, INDs, BLAs, formatted according to international eCTD requirements required. (SEND data and Datasets experience is a required)

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, CTIS)

Knowledge of publishing tools (e.g., DXC, eCTD Xpress, ISI Toolbox, Lorenz)

Experience with StartingPoint Tools / Templates preferred.

Able to work with tight timelines and achieve first-time-right submissions with zero health agency rejection(s)

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

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

Highly motivated, organized, and detail-oriented team player

Positive attitude and ability to effectively collaborate with peers, stakeholders, and cross-functional colleagues in a global team environment

Strong communication and business writing skills