· Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative
development issues and monitors changes in the regulatory environment in nominated region to support and advise
· Provides strategic regulatory advice support for product developments regional therapy area
· Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are
· Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
· Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market
legislation and requirements that impact on new and existing product registrations
· Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and
effective submissions, approvals and other product maintenance activities
· Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the
· Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in
place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory
personnel in markets have an appropriate knowledge of quality and compliance
· Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration