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RA - Specialist/Senior Specialist/Associate Manager

Location Beijing Municipality, China Shanghai, Shanghai Municipality, China Job ID R-119059 Date posted 12/09/2021
  • 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 (i.e. intellectual property, product information and strategic information)
    • Disclose potential breach of codes or conduct
    • Follow SOP requirements especially on documentation
  • Implement regulatory strategies to achieve rapid and high quality approval and facilitate rapid launch.
    • Coordinate with key stakeholders (local regulatory authority, local MC and International Regulatory Affairs Group etc.) to achieve rapid/ high quality submissions and approvals
    • Prepare and produce high quality regulatory submissions
    • Monitor registration process and promptly report whenever necessary
    • Actively communicate with CDE reviewers for technical discussion and Panel Meeting 
    • Develop artwork required for packaging and coordinate with logistic staff to facilitate rapid launch
  • Maintain product licenses through timely renewal to high standard
    • Monitor and promptly report status of all product licenses
    • Implement submission plan for products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on time
    • Maintain complete documentation records.
  • Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders
    • Maintain and update local and global regulatory support and information systems
    • Communicate changes to regulatory status to all stakeholders
    • Provide appropriate support to other functions
  • Under supervision: establish relationship with local regulatory authorities.
    • Build up AZ’s good image through high professional standard of application, response to enquiries etc.
    • Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings
  • Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory influence through company initiatives and/or industry association joint forces.
    • Maintain up-to-date knowledge of local regulatory environment
    • Communicate changes of local regulatory environment
  • Assist issue Management.
    • Provide detailed information on regulatory status of affected products
    • Undertake assigned follow-up action where necessary
  • Effective team work
    • Actively participate in team working
    • Share best practice examples & learning with the team and regional/global colleagues

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056702 C RGPD R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.