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Sr. Specialist/Associate Manager, Regulatory Affairs - Cell Therapy

Company

AstraZeneca

Location

Daxing District, Beijing

Type

Full time

  • Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs.

    Align with the values and vision of AZ

    Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, AZ code of conduct

    Maintain company confidentiality ( intellectual property, product information and strategic information)

    Disclose potential breach of codes or conduct

    Follow SOP requirements especially on documentation

  • For allocated portfolio develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch.

    Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy

    Assist in ensuring local regulatory strategies are consistent with global product strategies and local priorities

    Develop regulatory plan...

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