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Regulatory Affairs - Specialist

  • GE Healthcare
  • Experienced
  • Posted 5/8/2017 3:12:56 PM
  • 2858515
  • Job Function: Quality
  • Business Segment: Healthcare Life Sciences
Location(s): Italy; Milan


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Role Summary:
This position works within a team of Regulatory Affairs professionals to ensure regulatory compliance of GEHC pharmaceutical products, at national level.

Essential Responsibilities:

  • Ensures regulatory compliance and optimization of the quality processes relevant to submissions, and post submission questions for GEHC medicinal products in Italy
  • Investigates regulatory history of similar products to assess approval implications
  • Conducts research on submission requirements and options
  • Assists in monitoring and reporting project timelines
  • Responds to RA information requests
  • Communicates license approvals when received
  • Reviews promotion material ensuring it is consistent with approved claims for regulated products
  • Assists in the preparation of submission packages for local agency in compliance with specific local requirements
  • Supports the local pharmacovigilance responsible pharmacovigilance
  • Supports regulatory inspections as required
  • Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager

    Qualifications/Requirements:
    • University degree in scientific areas
    • Significant experience in regulatory affairs
    • Ability to communicate effectively in English (both written and oral)
    • Demonstrated experience and proficiency with MS Office word processing, spreadsheet,
    • presentation, and database applications.
    • Quality Specific Goals: Aware of and comply with the GEHC Quality Manual, Quality
    • Management System, Quality Management Policy, Quality Goals, and applicable laws and
    • regulations as they apply to this job type/position
    • Complete all planned Quality & Compliance training within the defined deadlines
    • Identify and report any quality or compliance concerns and take immediate corrective action as required
    • EU work permit

      Desired Characteristics:
      • Strong experience in a regulated industry is preferred
      • Ability to work independently in fast-paced environment with little supervision
      • Ability to adapt to constant change and influence positive change effectively
      • Attention to Detail and Results-Oriented
      • Ability to understand technical documentation and execute associated procedure

        Locations: Italy; Milan
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