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    • Global Regulatory Affairs Specialist - Parma - Chiesi Usa, Inc.

    Chiesi Usa, Inc.
    Chiesi Usa, Inc. Parma

    3 settimane fa

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    Descrizione

    Global Regulatory Affairs Specialist Role Overview

    Chiesi USA, Inc. is seeking a skilled Global Regulatory Affairs Specialist to join our team. This individual will play a key role in defining and executing the company's regulatory strategy, working closely with cross-functional teams to ensure compliance with global regulatory requirements.

    Main Responsibilities

    • Serve as a regional/local regulatory lead and point of contact for Health Authorities
    • Contribute to the development of global HA interaction strategy
    • Develop Health Authority engagement and interaction plans
    • Ensure complete and accurate communication/interaction with relevant HAs
    • Lead regulatory subteam to ensure NDA/MAA/Extensions/Variations filings meet project timelines
    • Collaborate with other GRT members on regulated documents and operational activities

    Requirements

    • Around 3 years' experience in Regulatory Affairs
    • Master's degree in Life Sciences
    • Fluent English language skills

    About Us

    Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience. We operate in 31 countries with more than 7,000 employees and are proud to be the largest global pharmaceutical group to be awarded B Corp Certification. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.

    We offer a dynamic, fast-growing, challenging, and friendly environment with opportunities for continuous learning and development. Our people are our most valuable asset, and we invest in their well-being and growth.

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