Typical Accountabilities

• For assigned digital solution projects, develop and implement aligned 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 in conjunction with key stakeholders, ensure allocation of adequate resources and deliver plans on time, and implement the aligned regulatory plan.
  • Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch.
  • Assist interactions with local HA when needed
• Maintain the awareness and shape the regulatory environment relevant to the assigned products/projects.
  • Monitor and understand 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
• Actively develop excellent relationship with local regulatory authorities and external stakeholders with support from seniors.
  • 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 at project level
  • Provide detailed analysis on regulatory status of affected products, working with partner together (when applicable)
  • Develop and undertake assigned follow-up action where necessary
  • Working collaboratively with cross-fucntional team members & external partners
• 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

Essential

Education, Qualifications

• Bachelor or above in Pharmacy, Medical, Biology or Data Science, IT related field

Skills

• 3+ years of experience in medical device  (class II/III) development environment & product registration process. SaMD experience is a strong plus.
• Excellent learning agility;
• Capable to understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies and do impact analysis
• Excellent verbal and written communication skills with strong communication capability.
• A collaborative teamplayer, with strong ability in building partnerships among peers
• Quality mindset with a keen sense of urgency and priority
• Good project management skills

Experience

• > 3 years experience in related positions.
• Good track record; experience in SaMD/medical device industry

  【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 

  阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.