As the Regulatory CMC Associate Director for AsiaPacific you will be the prime driver of the strategic direction for the Asia Pacific Regulatory Intelligence Team. You will lead an efficient and effective team to deliver CMC Regulatory advice and direction.

You will ensure effective planning and information sharing activities with the key customers interface groups (within Operations, Global Regulatory Affairs and Commercial) and Operations Regulatory to support regulatory strategies, issue resolution and continuous supply.

You will oversee performance standards that support maintenance of the license to operate and will develop senior level contacts, in particular with Global Regulatory affairs, Global Operations, Regional Supply organisation and Marketing Companies, to resolve issues that occur.

There is a requirement to set priorities and lead high rate of legislative changes. You will instigate and actively oversee changes and uncertainties with a degree of autonomy as well as spending time leading cross functional or global projects/networks or representing Operations.

You will be expected to provide strategic, tactical, operational regulatory CMC expertise and direction to AstraZeneca products and project teams in support of drug products throughout the life cycle and proactively share any new regulatory intelligence. You will anticipate and proactively minimise risks using evaluative judgements in complicated or novel situations. You will ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to development of new guidance, policy and processes. You will support proactive management of AZ strategies in response to the changing regulatory landscape within AsiaPacific and the CMC regulatory intelligence trends across the region. You will be a senior member of the department and therefore participate in leadership team meetings.

Key Accountabilities

• This is a global role with the need to develop cross functional contacts across a number of AZ functions. There will be a need to handle sensitive, international relationships, eg in markets such as Japan and China where well-developed cultural sensitivity will also be required.
• Timely communication to Operations Regulatory to inform regulatory strategies, secure supply in AsiaPacific and raise to the GQSC leadership team when required.
• Providing concise guidance on current CMC regulatory requirements to support business tactical or strategic supply planning. Responsible for provision of Regulatory expertise to cross functional teams and Operations leaders within the organisation.
• Optimizing the performance of the Asia Pacific Regulatory intelligence team
• Managing, developing and coordinating a team of professional staff, with key regulatory and technical skills.
• Ensure the effective deployment of resources within the team and in co-operation with other business units in Operations Regulatory to deliver business objectives.
• Add value through others; to lead and develop staff to a shared defined standard.
• Drive and deliver performance standards and improvements, issue resolution, through ongoing change and uncertainty.
• Responsible for the tactical and operations implementation of supply/demand requirements which arise from the key customers groups.
• Maintaini Lean principles within area of responsibility.
• Ensure adherence to SHE and compliance standards within the team.

Required Skills & Knowledge

• Degree or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry.
• Significant experience of Regulatory CMC and/or pharmaceutical and/or manufacturing and/or quality organisation.
• Deep understanding of cGMP requirements
• Breadth of knowledge of manufacturing, project, technical and regulatory management.
• People management, customer service and change management /project implementation.
• Fluent written and spoken Mandarin.
• Excellent written and spoken English

Preferred Skills & Knowledge

• Post graduate qualification
• Business, financial and supply chain understanding/awareness
• Deep understanding of regulatory affairs in Asia Pac region. Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
• Lean manufacturing principles, understanding, experience and practitioner
• Product and process knowledge
• Experience of leading teams
• Professional capabilities
• End to end supply chain principles
• Lean approach
• Quality & Compliance Management
• Quality Risk Management Team Development

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 nondiscrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.