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

Amgen (company)


Posted on : 01 May 2017

Project Description

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 department
  • Manage outsourced resources
  • Take part in the career and skills development of staff members
  • Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
  • Manage the preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards
  • Manage the creation and submission of regulatory dossiers across regions according to local requirements and agreed upon timelines
  • Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
  • Contribute to the development of the strategy for communicating with global health authorities
  • Represent departmental expertise on global work streams
  • Initiate, lead and manage process development and improvement
  • Lead information system and software update projects as well as ongoing system validations from a publishing perspective
  • Develop and report publishing metrics to senior management
  • Provide technical support in regulatory systems



Basic Qualifications 
  • Bachelor s degree and 5 years of regulatory experience
OR
  • Associate s degree and 10 years of regulatory experience
OR
  • High school diploma / GED and 12 years of regulatory experience



Preferred Qualifications 
  • Experience working in and leading teams
  • Knowledge of the industry and business principles for a regulatory operations department
  • Experience managing relationships with contributing functions and affiliates
  • Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications
  • Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications
  • Strong project management skills specifically related to regulatory projects
  • Expert knowledge of eCTD, US & CA eCTD Specifications and eCTD software
  • Expert knowledge of Emerging Markets Marketing Application submission requirements, country specifications, and software used
  • Expert knowledge of International Clinical Trial and Pediatric submission requirements, country specifications, and software used
  • Expertise in MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishing
  • Industry experience
  • Experience in a regulatory operations-focused role
  • Experience liaising with global regulatory authorities as it pertains to regulatory submissions
  • Expert knowledge in regional agency requirements for submissions
  • Expertise with standard software utilized by regulatory publishing groups

Locations

Canada Mississauga

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