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Submissions Manager, Regulatory Operations

Location: Cambridge, Massachusetts
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The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The Submission Manager provides regulatory operations expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions.

Here’s What You’ll Do:

Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.

As a global submissions’ expert, ensure the project team has awareness and knowledge of e?submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.

Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.

Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.

Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies.

Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements

Act as a subject matter expert for Moderna document management system.

Compile regulatory submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.

Lead and manage special projects as needed.

Here’s What You’ll Bring to the Table:

Bachelor’s degree in a scientific discipline or systems technology or equivalent

4-6 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)

Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools

Extensive knowledge of North American/Global submission standards (FDA, Health

Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.)

Knowledge of CDISC (ADaM, SEND, SDTM)

A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)

Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.

MS PowerPoint skills

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