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Associate Director, Regulatory Processes, AstraZeneca Gothenburg jobb i Mölndal på Randstad AB

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Associate Director, Regulatory Processes, AstraZeneca Gothenburg på Randstad AB

Associate Director, Regulatory Processes, AstraZeneca Gothenburg

Randstad AB Mölndal, Västra Götalands län Deltid


job description.

Associate Director, Regulatory Processes - Reg Process & Compliance team, Global Regulatory Excellence

Do you have experience from regulatory affairs in the pharmaceutical industry as well as strong leadership skills? Then this might be the role for you!

In this role, you will act as technical writer and project management support to ongoing procedural. You will be working with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. You will also be accountable to develop relationships across Regulatory Affairs and other relevant areas of AZ to execute the delivery of the processes strategy, priorities, alongside governance and management of the current procedural documents. This is a consulting assignment at AstraZeneca in Gothenburg.


responsibilities.

  • Support authoring and Project Management of procedural document such as Standard Operating Procedures, Work Instructions and Best Practice documentation
  • Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
  • Working with the Process Directors, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
  • Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
  • Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance support to regulatory teams and submissions.
  • 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
  • Identify issues and risks and propose options to mitigate them.
  • Support activities required to prepare for or in response to for GVP, GCP, GRP and GMP audits/inspections
  • Provide process training to relevant functional groups.
  • Contribute to communication and change management activities associated with process initiatives.
  • Working collaboratively to provide expertise and sharing best practices across all regions.


qualifications.

Essential
  • A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
  • 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/PhD in scientific discipline
  • Knowledge of new and developing regulatory and pharmacovigilance 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.
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.


application.

2021-09-16, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: Linnea Öster, [ Email address blocked ]
 
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Job ID: 201357684