Regulatory Submission Manager
- Experience Level
Hobson Prior are looking for a Regulatory Submission Manager to join a global biopharma organisation. In this role you will provide technical guidance to submission contributors and regional input regarding agency submission requirements.
- You will be the main SPARK point of contact to all Practices and PSTs for a given product.
- Being responsible for working with Global Regulatory Affairs, Patient Solutions Teams, Practices, Affiliates and Partners to ensure regional delivery or publishing, document management, tracking and planning as required.
- Working in partnership with the SPARK team, for the definition and management of global and regional publishing strategies for their assigned product to meet all regulatory submission requirements, ensuring that dossier structure, metadata and submission archives are compliant and consistent throughout the end-to-end submissions process, enabling effective re-use between submissions.
- Providing technical guidance to submission contributors and regional input regarding agency submission requirements.
- Publishing planning, working with authors to ensure submission readiness of documentation for assigned submissions and acts as product dossier historian.
- To lead or contribute to the development of global processes and standards for regulatory submissions and technology projects.
- Several years of experience in the pharmaceutical industry, with specific experience related to the preparation of regulatory dossiers and use of document management systems including electronic repository platforms with emphasis in submission publishing.
- Previous experience in the preparation of electronic submissions, including eCTD and other regional electronic formats with experience in managing eCTD lifecycles and validation.
- Experience in preparation of documents for regulatory submissions to meet authority requirements and company standards, including extensive knowledge of Microsoft Word and Adobe Acrobat functionality.
- Extensive knowledge of regional regulatory agency requirements for electronic submissions format and delivery including detailed knowledge of eCTD specifications and validation requirements. Some direct experience with regulatory agencies.
- Extensive knowledge of standard industry submission technologies and best practices related to submission preparation, archiving, and tracking.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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