• 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
