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    • GRA RA EU and International Specialist - Parma - IQVIA

    IQVIA
    IQVIA Parma

    1 mese fa

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    Job Description:

    GRA RA EU and International Specialist

    We are seeking a highly skilled GRA RA EU and International Specialist to join our team at Chiesi Farmaceutici, a top 50 pharmaceutical company with over 80 years of experience in the pharmaceutical and biotechnology industry.

    The successful candidate will work under the guidance of the regional Head, preparing and maintaining regulatory documents to support submissions to regional regulatory authorities. This will involve collaborating with consultants, partners, and affiliates to plan, coordinate, and manage regulatory submissions throughout the life cycle of Global Rare Disease products.

    The ideal candidate will have experience in the life cycle management of regulatory filing, with a strong attention to detail and quality of documents and processes. They will also possess well-developed written and oral communication and listening skills, as well as analytical and problem-solving skills.

    Responsibilities:

    • Prepare, compile, and maintain regulatory documents to support submissions to regional regulatory authorities.
    • Plan, coordinate, and manage regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products.
    • Critically review regulatory submission documents and make recommendations for improvement.
    • Contribute to the development of processes and Standard Operating Documents for Global Rare Disease RA.
    • Provide regulatory guidance to colleagues from other functional areas.
    • Prepare responses to questions and/or information requests from regulatory agencies.
    • Liaise with internal and external customers to request and obtain data relevant to submissions.
    • Use data management systems to track regulatory information.

    Requirements:

    • Experience in regulatory affairs in EU or INT or both at corporate level in a multinational company.
    • Ability to work under supervision in the preparation of high-quality submissions and submission documents.
    • Strong attention to details and quality of documents and processes.
    • Well-developed written and oral communication and listening skills.
    • Well-developed time management skills and demonstrated ability to manage complex assignments.
    • Well-developed analytical and problem-solving skills.
    • Ability to work independently and as part of a team.
    • English language proficiency from advanced to fluency.
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