The following outlines dossier execution activities required for managing, coordinating, creating, and delivering registration dossiers (submissions) delivered to the client’s country office or submitted directly to a Board of Health (BoH).

Working in partnership with and in support of Regulatory Strategists, the Submission Manager is responsible for dossier execution in support of maintaining or obtaining drug approval of the client’s regulatory portfolio. Partnering with internal and external partners, the incumbent confirms the appropriate components required to support the dossier in line with regional and national requirements, confirms and/or establishes dossier timelines and subsequently project manages receipt of the documents from the authors/contributors through to submission at the Regulatory Authority. In parallel the incumbent assumes responsibility to assure dossier status through timely and accurate maintenance of dossier information in regulatory planning and document management systems.

Dossier planning and compilation can take place over days, weeks or months from trigger to submission and will involve coordination with others regarding product information delivered to multiple Boards of Health. Multiple submission types at different stages may be managed in parallel, related to product, dossier type or country assignments/requirements.

Works with colleagues from multiple regions in order to deliver a dossier that meets the individual national content and technical (such as but not limited to eCTD, NeES and Paper) requirements for which the submission is targeted (Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and United States)

• Proactively enters and maintains critical regulatory information relating to assigned submissions within required systems and to required standards and timelines.

• Through active management of status and expected deliverables, identifies risks and partners with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of submissions while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and/or document management system(s).

• Delivers electronic and paper regulatory submissions through co-ordination and execution to requirements and standards of each submission and national markets.

• Maintains a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier format and translation requirements as required.

• Assists with interpretation of regulatory technical guidelines in order to produce business requirements and ensure that those requirements are implemented where appropriate at local level.

• Adheres to the required use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.

• As required, participates in implementation of national and regional process efficiencies and project learning sessions.