Manager, Regulatory Operations (Publishing)
Job Summary
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.
Key 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.
Regulatory 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.
Veeva Vault RIM Administration and Publishing:
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.
Process Improvement and Compliance:
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.
Leadership and Team Development:
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.
Qualifications
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 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.
Pay
The anticipated base pay range for this role is $137,500-168,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options.
Equal Opportunity Employer
We are an Equal Opportunity Employer.