Job Description
Location: Warsaw, Poland
Hybrid model of work: 3 days in office, 2 remote per week
As Regulatory Process Lead, role holderleadtheir nominated area within Regulatory Processes (nominated areas include core Regulatory business processes such as Clinical TrialApplication, Labelling, Marketing Application, License Maintenance and Regulatory Information Management)
- Accountabilities include design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes,technologyand 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
- Owns and is accountable for thelong termstewardship of their nominatedgroup of Processes area andfor successful delivery of the business benefits.
- Fulfillall 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” andefficient and effective holistic issue management that results in deliveryto addressbusiness 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,technologyand services within the Regulatory area they lead.
- Ensure customer requirements are understood, critically evaluated,prioritisedand addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resourcesrequiredto 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.
- Partnerwith Systemsteam counterparts to ensure an integrated andholistic approachto processes and systems.
- Act as the primary point of escalation for personnel for any risks and issuesidentifiedwithin the assigned area.
- Work with the department leader, and other stakeholders tomonitorthe 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 trendsidentifiedthrough the Quality & Risk Management process
- Activelyseekand promote creative and innovative ideas to drive performance and bringnew solutionsto customers
- Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activitiesrequiredto ensure license tooperateand 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.
- 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, continuousimprovementand 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
- Demonstratedexcellent skillsin:written and verbal communication
- Able to work with high degree of autonomy
- Able torepresentAstraZeneca externally whererequired
- PhD in scientific discipline
- Knowledge of newand developingregulatory and pharmacovigilance expectations
- Key capabilities:
- Understanding of governance processes
- Process improvement (egLeanmethodology)
- 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.
