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Regulatory Affairs Specialist, Bulgaria-135487 - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresBulgaria,
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Regulatory Affairs Specialist, Bulgaria-135487

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  • PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 15,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit .

    Now a great opportunity exists for University graduates to join our Regulatory Affairs team in Sofia at the position of:Regulatory Affairs SpecialistThe
    Regulatory Affairs Specialist provides regulatory advice and carries out
    projects in the provision of regulatory affairs services:• Acts as liaison with internal stakeholders in the provision of these services.
    Works with the Regulatory Affairs Management to perform the day to
    day operational aspects of the Department such as: preparation and
    assembly of global regulatory submissions, review and assessment of
    regulatory documents. • Interfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
    Develops and maintains a cooperative working relationship with
    Project Managers and project team members for assigned projects. Advises
    and directs project team as to their responsibilities relative to
    regulatory strategy/submission activities. Acts as a key liaison between
    Regulatory Affairs Department and project team for assigned projects.QualificationsEducation and Experience:• Bachelor's Degree; degree in Pharmacy or Life Science is an advantage.•
    Previous regulatory experience, or combination of higher education/less
    experience or substitution of equivalent relevant work experience will
    be consideredan advantage.Knowledge, Skills and Abilities:• Some regulatory affairs experience is preferable but not mandatory.• An appreciation of the requirements, timelines and processes for regulatory applications worldwide is a valuable asset.• Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage.• Excellent English language communication skills, both verbal and in writing. •
    Computer skills (Microsoft office) and experience in applications used
    in clinical trials (eTMF, CTMS) would be an advantage.• Good organizational and planning skills. Ability for multiple project tasking.• Proven ability to work effectively in a team, including in a multinational one.• Problem solving skills and strong attention to detail.

    In order to apply, please submit your CV and motivation letter in English.


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