Regulatory Affairs - Manager
• Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs.
o Align with the values and vision of AZ
o Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, AZ code of conduct
o Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
o Disclose potential breach of codes or conduct
o Follow SOP requirements especially on documentation
• Implement regulatory strategies to achieve rapid and high quality approval and facilitate rapid launch.
o Coordinate with key stakeholders (local regulatory authority, local MC and International Regulatory Affairs Group etc.) to achieve rapid/ high quality submissions and approvals
o Prepare and produce high quality regulatory submissions
o Monitor registration process and promptly report whenever necessary
o Actively communicate with CDE reviewers for technical discussion and Panel Meeting
o Develop artwork required for packaging and coordinate with logistic staff to facilitate rapid launch
• Maintain product licenses through timely renewal to high standard
o Monitor and promptly report status of all product licenses
o Implement submission plan for products maintenance (license, amendments to update registration files etc.) as approved and deliver plans on time
o Maintain complete documentation records.
• Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders
o Maintain and update local and global regulatory support and information systems
o Communicate changes to regulatory status to all stakeholders
o Provide appropriate support to other functions
• Under supervision: establish relationship with local regulatory authorities.
o Build up AZ’s good image through high professional standard of application, response to enquiries etc.
o Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives or trainings
• Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory influence through company initiatives and/or industry association joint forces.
o Maintain up-to-date knowledge of local regulatory environment
o Communicate changes of local regulatory environment
• Assist issue Management.
o Provide detailed information on regulatory status of affected products
o Undertake assigned follow-up action where necessary
• Effective team work
o Actively participate in team working
o Share best practice examples & learning with the team and regional/global colleagues
• Bachelor or above in Pharmacy, Medical, Biology or related field
• Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a major pharmaceutical company.
• Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.
• Project management primary lever skill
• Chinese and English (proficiency level)
• Computer skill: word, excel, power point
• ＞ 2 years experience in below positions.
• Experience in drug development, or manufacturing and QA/QC is preferred
• China Pharmacist/Physician License is plus.
【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.
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.