Informacje o stanowisku

Social network you want to login/join with:

Associate Director, Regulatory Process, Warsaw

Client:

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference: 33c8c11a5ea5

Job Views: 14

Posted: 23.01.2025

Expiry Date: 09.03.2025

Job Description:

Working with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. Specifically for this role the focus is intended to be CMC variation process and CMC contribution to overall Regulatory Business Processes.

Accountable to develop relationships across Regulatory Affairs and other relevant areas of AZ to execute the delivery of the process strategy, priorities, alongside governance and management of the current procedural documents and associated training deliverables.

• Identify opportunities for and drive the enhancement of existing processes through knowledge of internal and external environment.
• Work with the Process Directors and CMC Regulatory experts to develop, establish, monitor, report and assess global KPIs related to regulatory data reporting.
• Utilise regulatory knowledge to maintain and support the global inspection readiness strategy.
• Provide process or compliance support to regulatory teams and submissions using deep understanding of regulatory processes and regulations.
• Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
• Coordinate and own 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.
• 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 to improve quality, compliance and efficiency of deliverables for the overall group.
• Monitor, analyze and trend 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 support activities for GRP and GMP audits/inspections.
• Deliver on project assignments supporting the business, representation or leadership on global cross-functional task forces.
• Provide process training to relevant functional groups in close collaboration with CMC functional Subject Matter Experts (SMEs).
• 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.
• Build relationships with stakeholders and customers to support regulatory activities and responsibilities.
• Work collaboratively to provide expertise and share best practices across all regions and in all partnerships.

Minimum Requirements:

• A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory).
• 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.
• Excellent written and verbal communication skills.
• Proven ability to work across cultures.
• MSC in scientific discipline.
• Knowledge of new and developing regulatory 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.

Warszawa - Oferty pracy w okolicznych lokalizacjach