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
Academic / Professional Qualification
x Bachelor degree or above in Pharmacy, Medical, Biology or related field.
Technical / Skills Training pharmaceutical company.
x Understand the current regulatory practices and regulation in China.
x Strong collaboration across teams.
x Good project management skill.
x Fluent in both oral and written English.
x Good computer skill: word, excel, power point.
Working Experience
x Minimum 2 years’ experience in below position.
x Minimum 4 years working experience in regulatory affairs of MNC Pharma Company.