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Submissions Manager
Katalyst Healthcares & Life Sciences
South Plainfield, NJ (Onsite)
Full-Time
Responsibilities :
- 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 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 document management system and support Veeva RIM activities as needed.
- Compile regulatory submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product lifecycle information.
- Format documents as needed to ensure they are submission ready.
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