• 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
• For allocated portfolio develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch.
o Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy
o Assist in ensuring local regulatory strategies are consistent with global product strategies and local priorities
o Develop regulatory plan in conjunction with key stakeholders, ensure allocation of adequate resources and deliver plans on time
o Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
• Maintain product licenses in assigned portfolio through timely renewal to a high standard.
o Monitor status of product licenses
o Project manage changes in product licenses and coordinate with other changes, planned and in progress
o Maintain complete documentation records
o Communicate changes to license status promptly
• Maintain the awareness and shape the regulatory environment relevant to the assigned portfolio.
o Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products
o Communicate the impact of changes to key stakeholders.
o Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes
• Actively develop excellent relationship with local regulatory authorities and external stakeholders.
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
• Drive issue Management.
o Provide detailed analysis on regulatory status of affected products
o Develop and undertake assigned follow-up action where necessary
• Supervise and coach junior staff to execute the regulatory activity and achieve the business objectives.
o Supervise, coach, support junior staff.
o Encourages the sharing of best practices.
o Take decision and accountability for actions.
o Enhance positive attitudes and mindset. Demonstrate confidence and conviction.
o Challenge status quo for continuous improvement.
o Help build an open and trusting atmosphere.
