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Regulatory Affairs - Sr. Manager

Location Beijing Municipality, China Shanghai, Shanghai Municipality, China Job ID R-118984 Date posted 10/09/2021
  • Be responsible for multiple products as Regulatory Lead. Set strategic regulatory direction for China portfolio, and as regulatory expert to lead the execution of submission/approval as well as the HA communication.     
    • For allocated products develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch as Regulatory lead and compliance with GRP requirements.
      • 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 in conjunction with key stakeholders, ensure allocation of adequate resources and deliver plans on time
    • Maintain product licenses in assigned portfolio through timely renewal to a high standard and compliance with GRP requirements.
      • Monitor status of product licenses
      • Project manage changes in product licenses and coordinate with other changes, planned and in progress
      • Maintain complete documentation records
      • Communicate changes to license status promptly
  • Maintain the awareness and shape the regulatory environment, proactively working on policy interpretation and policy advocacy.
    • Monitor, understand and interpret the impact of external changes in the regulatory and political environment that will impact on the assigned products
    • Communicate the impact of changes to key stakeholders.
    • Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes
  • Lead the stakeholder management and be good at the complexity management. 
    • 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
    • Drive issue Management.
      • Provide detailed analysis and lead cross functional teams to address critical regulatory issues.
      • Develop and undertake assigned follow-up action where necessary
  • Supervise and coach junior staff to execute the regulatory activity and achieve the business objectives.
    • Supervise, coach, support junior staff.
    • Encourages the sharing of best practices.
    • Take decision and accountability for actions.
    • Enhance positive attitudes and mindset. Demonstrate confidence and conviction.
    • Challenge status quo for continuous improvement.
    • Help build an open and trusting atmosphere.

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.

10001059 F RGRO 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.