46 days ago on careers.peopleclick.com

Regulatory Compliance Officer


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Regulatory Compliance Officer

Regulatory Compliance Officer
  • Requisition ID:142657
  • Position:Full time
  • Open date:12.09.2016 09:34
  • Functional area:Quality
  • Location:Nyon
  • Required degrees:Phd/Doctorate
  • Relocation:No
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    Basic qualifications:
    Bachelor in Life Sciences with proficiency in English or equivalent
    French : fluent (oral and written)
    English : fluent (oral and written)
    MS Office : good command
    LIMS, SAP, TrackWise, Register, DIGA, Opal : basic knowledge

    Preferred qualifications:
    • 3-5 years’ experience in a Pharmaceutical Regulatory/Quality Environment.
    • Driven for accurate and detailed results, while exercising good judgement.
    • Striving for continuous Improvement in the systems and processes supporting regulatory compliance.

     Compliance / Technical writing:
    - Verify regulatory compliance of registered dossiers
    - Evaluate gaps and take part in regulatory remediation strategy
    - Manage corrective actions that are being put in place
    - Prepare necessary change controls for variations
    - Write technical documents to be included in or related to regulatory dossiers and manage approval workflow
    - Manage requests for modification and creation of new documents
    - Follow up on comprehensiveness and quality of feedback received from countries
    - Manage compliance request from local HAs
    - Coordinate answers to questions from local HAs
    - Get escalation process under way in case of non-compliance
    - Review compliance and approve technical specifications in various systems (LIMS, SAP, DIGA)

     Security :
    - Apply and support Novartis HSE requirements
    - Anticipate change consequences on health, security and environment

     GMP :
    - Enforce and drive GMP standards
    - Maintain and approve local procedures related to the activity
    - Ensure that the state of Change Controls records reflects the current situation and are in full compliance with Quality Modules
    - GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system

     Administration :
    - Ensure the progress of the records and report periodically their status

     Communication :
    - Communicate with ease with internal departments and with local affiliates using all available tools

     Continuous Improvement:
    - Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work

    Key interactions :
    - Nyon Plant : QC, Analytical Services, Technical, Supply, Compliance & Auditing
    - Global and local Regulatory Affairs

    Contact information:
    You may apply for this position online by selecting the Apply now button.

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