Director Regulatory Process

5 miesięcy temu

Warsaw, Polska AstraZeneca Pełny etat

Act as Regulatory Process Lead, to lead their nominated area within Regulatory Processes. Regulatory Nominated Areas Include: Clinical Trials, License Maintenance, Marketing Application and Regulatory

Information a Management. Responsiilities include: Design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes, technology and services within the area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.Accountable to develop relationships across Regulatory Affairs organisations and other relevant areas of AZ to execute the delivery of the process's strategy, priorities, alongside governance and management of the current procedural documents

Typical Accountabilities :

Accountable for the oversight, lifecycle management and strategic planning and development of nominated area and the Regulatory owned processes and procedural documents of their nominated area and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies. Owns and is accountable for the long term stewardship of their nominated area and for successful delivery of the business benefits. Fulfill all required responsibilities of BPO role as described in R&D Process Governance framework, when tasks delegated to Associate Directors/Manager/SMEs accountability for setting and communicating strategy and timelines remain. Accountable to demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement. Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement of processes, technology and services within the Regulatory area they lead. Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements and provide feedback and clear rationale for any areas that will not be addressed. Ensures that internal processes are fit for purpose, working with relevant stakeholders to improve processes. Partner with Systems team counterparts to ensure an integrated and holistic approach to processes and systems. Act as the primary point of escalation for personnel for any risks and issues identified within the assigned area. Work with the Head of Reg Process and Compliance and other stakeholders to monitor the overall performance of the processes and technology within the nominated area. TMonitor agreed key performance indicators, oversee the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through theQuality & Risk Management process Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industryintelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance Project manage projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross functional teams. Where applicable, in partnership with peers (Other Nominated Area Leads) establish, foster and facilitate a top tier partnership relationship with the outsource provider. Ensures that all internal and external relationships and interfaces are managed effectively.

Essential :

University degree or equivalent qualification in relevant scientific discipline Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role. Experience from authoring standards documents (Standard Operating procedures) Experience from development and provision of training through virtual meetings and other media Experience of leadership of team, either as line manager or project leader Experience in outsourcing and partnership with external vendors and to manage multiple stakeholders Extensive knowledge in project management skills, specifically leading teams Demonstrated excellent skills in: written and verbal communication Able to work with high degree of autonomy Able to represent AstraZeneca externally where required

Desirable :

PhD in scientific discipline · Knowledge of new and developing regulatory and pharmacovigilance expectations

Key capabilities:

Understanding of governance processes Process improvement (eg Lean methodology) Collaboration/co-ordination Financial awareness Ability to influence without authority Open to multiple perspectives Balanced perspective Solution focused Experience with inspection activities

Date Posted

15-May-2024

Closing Date

03-Jun-2024

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