Manager, Regulatory Compliance

Employer
AstraZeneca
Location
Masovia, Warsaw, Poland
Salary
Negotiable
Closing date
24 Sep 2020

View more

Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
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Working with the Processes leads, Process Principals and Compliance Principal, supporting task related to management of AstraZeneca processes including implementation compliance, performance and inspection readiness.

Supporting Regulatory Compliance Principal with developing relationships across Regulatory Affairs groups and other relevant areas of AZ to execute the delivery of the compliance strategy, priorities, alongside governance and management of the current procedural documents.

Responsibilities:

  • Working with the Process leads and Principals, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to and regulatory data reporting.
  • Management of Licence to operate activities e.g. compliance data collection and complilation
  • Performing the collection and monitoring of compliance data.
  • Support monthly and annual cycles of KPI/Metric data for the Reg KPI dashboard, including Data extracts, review and analysis.
  • In collaboration with Head of Reg P&C and Process Leads support communications to relevant business groups to call out actions.
  • Following up on actions agreed based on compliance data
  • Using understanding of PV and Regulatory processes and regulations to provide support to regulatory process and compliance team
  • Reporting of status of Quality events and risks and preparing summaries for stakeholder groups/forum
  • Support owners of Quality issues or CAPAs in business to appropriately log in EQMS and manage actions to resolution
  • Promote a culture of continuous improvement, high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches.
  • Support training activities for relevant groups in R&D Regulatory Affairs groups in relation to Quality management and compliance monitoring activities
  • Support Coordination of activities in R&D Regulatory Affairs groups for issues managed through Operations Regulatory Deviation framework and Operations Issue Management team (IMTs).
  • Identify opportunities to improve and simplify the methodology in own area of work, provide practical solutions and drive to implementation.
  • Support and improve reporting tools and analysis processes and process metric /KPI data. Performing the monitoring, analysis and trending of data in own area of work.
  • Contribute to the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group.
  • Develop and improve reporting tools and analysis processes and technology.
  • Contibute to analysis and trending. Identify issues and risks and propose options to mitigate them.
  • Ensure that appropriate, up-to-date records are maintained for compliance
  • Identify issues and risks in own area of work and propose options to mitigate them.
  • Ensure that appropriate, up-to-date records are maintained for compliance
  • support activities for GVP, GCP, GRP and GMP audits/inspections
  • Support Delivery of improvement project assignments supporting the business,
  • Seek personal and professional development opportunities, and share knowledge gained in open forums
  • Contribute to communication and change management activities associated with compliance related initiatives.
  • Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities
  • Working collaboratively to provide expertise and sharing best practices across all regions

Education, Qualifications, Skills and Experience

Essential:

  • A science/pharmacy/nursing degree,
  • Experience in working cross-functionally
  • Administrative skills including Sharepoint online expertise
  • Good attention to detail
  • Excellent written and verbal communication skills
  • Proven ability to work across cultures
  • Strong collaboration skills
  • Able to work effectively as a member of a cross-functional or global team
  • Understanding of change management process
  • Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours

Desirable:

  • 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
  • Experience of working with reporting and analysis of data, preferably in support of compliance monitoring activities
  • Project Management skills

Interviews will be done on a rolling bases, therefore do apply as soon as possible

A global pharmaceutical company with a major UK presence. Our purpose is to push the boundaries of science to deliver life-changing medicines. The best way we can help patients is to be science-led and share this passion with the scientific, healthcare and business communities of the UK.

Please visit our Careers Hub

Contact Us
  • Academy House
  • 136 Hills Road
  • Cambridge
  • CB2 8PA
  • United Kingdom
  • 01582 837837
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