Typical Accountabilities

• Implement regulatory strategies to achieve in-time and high quality approval and facilitate full speed launch.
• Maintain product licenses through timely lifecycle management with high standard.
• Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders.
• Establish relationship with local regulatory authorities with the guidance of senior regulatory manager.
• Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory influence through company initiatives and/or industry association joint forces.
• Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs.

Education, Qualifications, Skills and Experience

Essential

Academic / Professional Qualification

• Bachelor degree or above in Pharmacy, Medical, Biology or related field.

Technical / Skills Training

• have a proven track record from a leading pharmaceutical company.
• Understand the current regulatory practices and regulation in China.
• Strong collaboration across teams.
• Good project management skill.
• Fluent in both oral and written English.
• Good computer skill: word, excel, power point.

Working Experience

• Minimum 2 years’ experience in below position.
• Minimum 4 years working experience in regulatory affairs of MNC Pharma Company.

【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。】