Sr. Manager, Global Regulatory Publishing

Replimune; Woburn (MA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

An innovative firm is looking for a Senior Manager in Global Regulatory Publishing who will play a crucial role in the preparation and submission of regulatory documents. This position offers a unique opportunity to lead a dynamic team, ensuring compliance with global health authority requirements. With a focus on collaboration and excellence, you will work closely with cross-functional teams to deliver high-quality submissions that can significantly impact patient care. If you are a detail-oriented professional with a passion for regulatory affairs and a commitment to improving cancer treatment, this role is perfect for you.

Benefits

Competitive Salary

Health Insurance

Retirement Plan

Flexible Work Hours

Remote Work Options

Professional Development Opportunities

Paid Time Off

Wellness Programs

Qualifications

• 5+ years of experience in regulatory publishing in biotech/pharmaceutical.
• Strong knowledge of global Clinical and Regulatory Health Agency requirements.

Responsibilities

• Oversee the planning, creation, and submission of regulatory submissions.
• Lead and manage submissions of MAA, CTIS, INDs, and BLAs.

Skills

Regulatory Publishing

eCTD Requirements

Veeva Vault RIM

Project Management

Analytical Thinking

Problem Solving

Interpersonal Skills

Communication Skills

Education

BA or BS degree

Tools

Veeva Vault RIM

DXC

eCTD Xpress

ISI Toolbox

Lorenz

Job description

Overview

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.

At Replimune, we live by our values:

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.

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, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity tocontribute 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

Key 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
• 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
• 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)
• Experience with Veeva Vault RIM is required. Experience with Veeva PromoMats preferred.
• 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