Manager, Regulatory Processes

Manager, Regulatory Processes

Location: Warsaw, hybrid work (at least 3 days from the office per week)

Working with the Processes Directors and Associate Directors, supporting tasks related to management of 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 assigned tasks in relation to processes strategy, priorities, alongside governance and management of the current procedural documents.

Typical Accountabilities:

• Collaborate with Process Directors and Associate Directors with enhancement of existing processes and procedural documents.
• Author and collaborate with SMEs to deliver assigned Job aid and supporting documents and templates.
• Working with the Process and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
• Maintain and continuously improve key customer facing service solutions for Process guidance and document access (such as SPOL sites, portals for tickets, Q&A etc).
• Coordinate specific tasks related to procedural document management to provide oversight to the regulatory process team
• Using understanding of Regulatory processes and regulations to provide support to regulatory process team
• Promote a culture of continuous improvement, high performance, flexibility and quality, emphasising a “can do” attitude and innovative approaches.
• Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation. Identify issues and risks in own area of work and propose options to mitigate them.
• Ensure that appropriate, up-to-date records are maintained for compliance
• Support activities for GVP, GCP, GRP and GMP audits/inspections
• Support Delivery of improvement project assignments supporting the business,
• Provide process training to relevant functional groups or support preparation of training material.
• Seek personal and professional development opportunities, and share knowledge gained in open forums
• Contribute to communication and change management activities associated with process initiatives.
• Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships
• 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
• Experience in working cross-functionally
• Administrative skills including Sharepoint online expertise
• Project Management skills
• Good attention to detail
• Excellent written and verbal communication skills in English
• Proven ability to work across cultures

Desirable:

• 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
• Experience of working with Procedural documents

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 authorisation and employment eligibility verification requirements.