Director, Regulatory Processes

AstraZeneca Poland - Warsaw Posted 11h First seen 11h

Location: Warsaw, Poland
Hybrid model of work: 3 days in office, 2 remote per week

As Regulatory Process Lead, role holder lead their nominated area within Regulatory Processes (nominated areas include core Regulatory business processes such as Clinical Trial Application, Labelling, Marketing Application, License Maintenance and Regulatory Information Management).    

Typical Accountabilities  

  • Accountabilities 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  

Key Responsibilities:  

  • Owns and is accountable for the long term stewardship of their nominated group of Processes 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 individual tasks are delegated to Associate Directors/Manager/SMEs Process Lead remain accountability for setting and communicating strategy and timelines.  
  • Demonstrate and contributes to a culture of “ownership”  and efficient and effective holistic issue management that results in delivery to address business need and includes top tier customer/stakeholder engagement.  
  • Engage and influence internal and external (outside Regulatory) 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 department leader, and other stakeholders to monitor the overall performance of the processes and technology within the nominated area.   
  • Monitor agreed key performance indicators, oversee the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through the Quality & 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 industry intelligence 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.  
  • 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 
  • Ability 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

22-lip-2026

Closing Date

04-sie-2026

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.