• Adherence to AZ and industry code of conduct, ethics and goodregulatory practices including AZC RA SOPs and other required SOPs.
• Support line manager to implement regulatory strategies to achieverapid and high quality approval and facilitate rapid launch.
• Maintain product licenses through timely renewal to high standard.
• Effectively manage the local and global regulatory supportsystems/information to ensure good coordination for all stakeholders.
• Maintain up-to-date knowledge of local regulatory environment, andcommunicate changes of local regulatory environment.
• Actively participate in team working.
Education, Qualifications
• Master or above in Pharmacy, Medical, Biology or related field
Skills
• Possess a high degree of honesty with a track record built on successstories and sound ethics, have a proven track record from a majorpharmaceutical company.
• Understand the current regulatory practices and regulation in China,the authority structure and relationship among different regulatory bodies.
• Project management primary level skill
• Chinese and English (proficiency level)
• Computer skill: word, excel, power point