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Regulatory Information Manager

Added on:
27 Nov 2019
Contract type:
Contract/Temporary
Reference:
T2611
Location:
Belgium

Description

Working Within the Regulatory Affairs Department of a Global Pharma Organisation the Regulatory Information Manager will Provide Effective Support, Training and Assistance to Colleagues to Enable Appropriate Data Stewardship and Process Ownership

ROLE

  • First-Line Business Support and End-User Training for Use of the Global License Tracking Database and Document Management System
  • Correct Data/Content Quality Issues as Necessary
  • Follow Up with The End Users, regarding Identified Data or Content Quality Issues and Identify Areas for Improvement
  • Quality Control Checks and Proof Reading on Data Entered into Global License Tracking and Regulatory Submissions
  • Authoring, Reviewing and Approving Documents, Including Validation Deliverables, SOPs, Release Notes, User Guides, Protocols, Reports and FAQs
  • Providing Input into User Requirements and Information on Related Processes and Systems Interfaces
  • Support with Queries regarding Data Definitions, Quality Standards etc
  • Communicate Concerns, Issues and Problems to Individuals, to Data Owners and Governance Bodies
  • Support with Health Authority Submissions, Inspections and Correspondence Activities
  • Contribute to Product Master Data Strategy and IDMP Requirements
  • Deviation and CAPA Management, Audit Readiness and Audit/Inspection Support

REQUIRED

  • Bachelor's Degree
  • 3+ Years of Experience in the Pharmaceutical Industry, with Specific Experience Related to Processing and Management of Regulatory Information
  • Minimum of 2 Years’ Experience in Supporting end Users to Enter and Maintain Product Information in a Registration Tracking Database
  • Ability to Bring Complex Assignments to Completion
  • Experience in Preparation and Delivery of Training Materials
  • Extensive Knowledge of Regional Regulatory Agency Requirements as Relates to Maintenance of Product Information and Submission Tracking
  • Extensive Knowledge of Registration Tracking Technologies, Document Best Practices Related to System Usage, Archiving and Tracking

REMUNERATION

  • Salary €41.50 P/H

RESPOND

  • Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV