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Regulatory Operations Publishing Manager (1 Year Contract) Mississauga Canada,  


Posted on : 01 May 2017

Project Description

The Regulatory Operations Manager will ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This manager supports the tactical execution and detailed deliverables to support a Global Regulatory Filing. The manger will manage and deliver every submission every time.Key responsibilities for this role include:Manage the functional areas of the departmentManage outsourced resourcesTake part in the career and skills development of staff membersEnsure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspectiveManage the preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standardsManage the creation and submission of regulatory dossiers across regions according to local requirements and agreed upon timelinesProvide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiersContribute to the development of the strategy for communicating with global health authoritiesRepresent departmental expertise on global work streamsInitiate, lead and manage process development and improvementLead information system and software update projects as well as ongoing system validations from a publishing perspectiveDevelop and report publishing metrics to senior managementProvide technical support in regulatory systemsBasic Qualifications Bachelor s degree and 5 years of regulatory experienceORAssociate s degree and 10 years of regulatory experienceORHigh school diploma / GED and 12 years of regulatory experiencePreferred Qualifications Experience working in and leading teamsKnowledge of the industry and business principles for a regulatory operations departmentExperience managing relationships with contributing functions and affiliatesExpertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing ApplicationsExpertise in the submission and maintenance of global Clinical Trial and Marketing ApplicationsStrong project management skills specifically related to regulatory projectsExpert knowledge of eCTD, US & CA eCTD Specifications and eCTD softwareExpert knowledge of Emerging Markets Marketing Application submission requirements, country specifications, and software usedExpert knowledge of International Clinical Trial and Pediatric submission requirements, country specifications, and software usedExpertise in MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishingIndustry experienceExperience in a regulatory operations-focused roleExperience liaising with global regulatory authorities as it pertains to regulatory submissionsExpert knowledge in regional agency requirements for submissionsExpertise with standard software utilized by regulatory publishing groups

Locations

Canada Mississauga

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