Associate Director, Regulatory Processes
Associate Director, Regulatory Processes
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Job Description
Associate Director Regulatory Processes
Location: Warsaw hybrid work (3 days from the office per week)
Working with the Processes Directors taking responsibility for the management of assigned AstraZeneca projects processes including implementation communication compliance performance and inspection readiness. Accountable to develop relationships across Regulatory Affairs and other relevant areas of AZ to execute the delivery of the processstrategy priorities alongside governance and management of the current procedural documents and associated training deliverables.
Typical Accountabilities:
- Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
- Working with the Process Directors and Regulatory experts to develop establish monitor report and assess global KPIs related to safety and regulatory data reporting.
- Utilise regulatory knowledge to maintain and support the global inspection readiness strategy.
- Using deep understanding of regulatory processes and regulations provide process or compliance support to regulatory teams and submissions.
- Establish a culture of continuous improvement high performance flexibility and quality emphasising a can do attitude and innovative approaches.
- Coordination and ownership of the lifecycle management of nominated processes enabling business continuity and compliance.
- Identify opportunities to improve and simplify the methodology in processes and guidance provide practical solutions and drive to implementation.
- Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships.
- Lead the development and/or enhancement of standards or techniques in order to improve the quality compliance and efficiency of deliverables for the overall group.
- Contribute to the monitoring analysis and trending of data.
- Identify issues and risks and propose options to mitigate them.
- Monitor interpret and validate current new and changing legislation and manage the impact of changes.
- Ensure that appropriate up-to-date records are maintained for compliance
- Participate and /or support activities for GVP GCP GRP and GMP audits/inspections
- Deliver on project assignments supporting the business e.g. representation or leadership on global cross-functional task forces.
- Provide process training to relevant functional groups.
- Seek personal and professional development opportunities and share knowledge gained in open forums
- May represent AZ on industry bodies
- Serve as the delegate where appropriate for the Process Directors
- Contribute to communication and change management activities associated with process initiatives.
- Building relationships with stakeholders and customers to support regulatory activities and responsibilities
- Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships
Education Qualifications Skills and Experience
Essential:
- A science/pharmacy/nursing degree with at least 5 years relevant experience (pharmaceutical regulatory safety and partnership)
- Experience in working cross-functionally
- Leadership skills including proven leadership of project teams experience
- Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
- Thorough knowledge of the drug development process
- Good attention to detail
- Excellent written and verbal communication skills
- Proven ability to work across cultures
Desirable:
- MSC in scientific discipline
- Knowledge of new and developing regulatory and pharmacovigilance expectations
- Knowledge of existing AstraZeneca external alliances and collaborative projects
- Knowledge of Regulatory operating model and organisation
- Experience of working in a global organisation preferably within the pharmaceuticals industry and of the drug development life cycle and commercial aspects of the industry
Date Posted
10-Jun-2025Closing Date
30-Jun-2025AstraZeneca 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.
Required Experience:
Director
Employment Type
Full-Time
