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.
Responsibilities:
- Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
- Working 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.
- 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 Performing 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 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 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.
- 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
Essential :
- 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
- 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 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
More Information
- Experience Level Junior
- Total Years Experience 5-10
- Radio field Option 1
- Dropdown field Option 2
- Multiple Select field Option 3
- Checkbox field Option 2
