Are you based in America and a QA specialist?
Well then this could be the job for you!
12 Month Contract
The Hub Submission Manager is accountable for operational management of regional and/or national regulatory dossiers to designated Health Authorities (HA’s)Based within WSR Submission Management, this role sits within a team working to tight, business-critical deadlines within a highly regulated environment.
* Execute, through use of standards and tools, designated operational tasks e.g. submission planning, document receipt, translation management, technical build and submittal to HA or via the applicable country office, conforming to regulatory submission milestones and applicable regulatory obligations.
* Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate.
* Partnering with product teams and/or third-party partners, the incumbent will be responsible for project management of activities, in support of regional and national regulatory submissions component build and delivery.
* Delivering project specific electronic and paper regulatory submissions.
* Including co-ordination and execution of solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and ensuring subsequent archival.
* Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
* Actively participate in the definition, investigation and implementation of national, regional and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
* Completion of assignments and tasks within a specific task force/project associated with electronic and paper submissions.
* Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
* Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
* Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
* Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
* Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
* Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor Engages Submission leader, business suppliers and other key regional representatives as appropriate, to agree on process and activities for opportunistic re-use of submission documentation for multiple national markets.
* Leads the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
Apply Back to search Xplore News