Associate Director, Regulatory Process

2 tygodni temu

Warszawa, Mazovia, Polska AstraZeneca Pełny etat

Working closely with the Processes Directors, the main responsibility of this role is to manage assigned AstraZeneca projects and processes, focusing on CMC variation process and its contribution to Regulatory Business Processes. Key tasks include:

  • Identifying and enhancing existing processes through knowledge of internal and external environment.
  • Developing global KPIs related to regulatory data reporting.
  • Maintaining regulatory knowledge to support global inspection readiness.
  • Providing process and compliance support to regulatory teams and submissions.
  • Establishing a culture of continuous improvement and high performance.
  • Coordinating the lifecycle management of processes.
  • Simplifying methodology in processes and providing practical solutions.
  • Promoting innovation and new ways of working to drive efficiency.
  • Improving the quality and efficiency of deliverables for the group.
  • Monitoring and analyzing data, identifying risks, and proposing mitigation options.
  • Managing the impact of changing legislation.
  • Maintaining up-to-date records for compliance.
  • Supporting audit/inspections and global cross-functional task forces.
  • Delivering process training to functional groups.
  • Building relationships with stakeholders to support regulatory activities.
  • Participating in communication and change management activities.

Essential :

  • A science/pharmacy/nursing degree with at least 5 years of relevant experience.
  • Cross-functional work experience.
  • Leadership skills, including leading project teams.
  • Thorough scientific knowledge of regulatory/pharmacovigilance and partnership issues.
  • Understanding of the drug development process.
  • Strong attention to detail.
  • Excellent written and verbal communication skills.
  • Ability to work effectively across cultures.

Desirable :

  • MSC in a scientific discipline.
  • Knowledge of new regulatory expectations.
  • Familiarity with AstraZeneca external alliances and projects.
  • Understanding of Regulatory operating model and organization.
  • Global organization work experience, preferably in the pharmaceutical industry.

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