Director Regulatory Process

2 tygodni temu

Warszawa, Mazovia, Polska AstraZeneca Pełny etat

Act as Regulatory Process Lead, to oversee their designated area within Regulatory Processes. Responsibilities include design, development, implementation, and maintenance of processes, technology, and services within the area, ensuring compliance with industry regulations and AstraZeneca Global and Local Policies. Develop relationships across Regulatory Affairs organizations and other relevant areas of AZ to execute process strategy and priorities.

Role Responsibilities:

  • Accountable for oversight, lifecycle management, and strategic planning of designated area and Regulatory processes.
  • Responsible for long-term stewardship and successful delivery of business benefits.
  • Demonstrate ownership culture and efficient issue management.
  • Engage internal and external stakeholders to drive process development and improvement.
  • Ensure customer requirements are prioritized and addressed.
  • Work with leadership to prioritize needs and allocate resources.
  • Ensure internal processes are effective and collaborate with stakeholders for process improvement.
  • Act as primary point of escalation for identified risks and issues.
  • Monitor process performance and oversee Corrective and Preventive Actions.
  • Promote innovative ideas for performance improvement and customer solutions.
  • Establish a global approach to gather regulatory and industry intelligence for continuous improvement.
  • Project manage to achieve targets and provide expert regulatory guidance in cross-functional teams.
  • Foster partnership relationships with outsource providers and manage internal & external interfaces effectively.

Essential Requirements:

  • University degree in relevant scientific discipline
  • Understanding of global regulatory requirements
  • Experience in business processes design, development, and implementation
  • Proficiency in authoring standards documents and providing training
  • Leadership experience and ability to manage multiple stakeholders
  • Project management skills and strong communication abilities
  • Ability to work autonomously and represent AstraZeneca externally

Desirable Qualifications:

  • PhD in a scientific discipline
  • Knowledge of emerging regulatory expectations

Key Capabilities:

  • Understanding of governance processes
  • Process improvement skills
  • Effective collaboration and coordination
  • Financial acumen
  • Ability to influence without authority
  • Open-minded and balanced perspective
  • Solution-oriented mindset
  • Experience with inspection activities

Date Posted:

15-May-2024

Closing Date:

03-Jun-2024

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