Operations Regulatory CMC - Specialist

PharmaRelations

Sweden - Gothenburg

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We are looking for a consultant for the following assignment at AstraZeneca in Gotheburg:
Do you have expertise in regulatory and overall understanding of GxP requirements? Are you highly collaborative and like contributing to clear instructions and implementing process improvements? This opportunity as Processes Specialist in the Regulatory Process and Compliance team might be the right opportunity for you.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means putting patients first, doing the right thing and working together to make the impossible a reality. If you are swift to action, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Global Regulatory Excellence’s vision is to Leading enterprise-wide regulatory strategies, policy and delivery - so that no patient waits. In the Regulatory Process and Compliance team we network collaboratively to enable our customer groups to operate efficient processes in a compliant manner.

What you’ll do

As a Processes Specialist in the Regulatory Process and Compliance team you will be working with the Process team members and taking responsibility for the management of assigned tasks related to procedural document management. You will act as technical writer and reviewer, and support project management to ongoing procedural document update program.
You will be accountable to execute the delivery of the authoring and lifecycle management of current procedural documents. We hope that you have the drive to establish a culture of continuous improvement, high performance, flexibility and quality, emphasizing a “can do” attitude and ensuring high standards of quality in all outputs.

Other key responsibilities in this position:
• Identify opportunities for and drives the enhancement of existing processes and procedural documents
• Using understanding of regulatory processes and regulations to provide support to regulatory process team
• Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions
• Review and verify documents and data for accuracy and completeness
• Collaborate with team members to ensure high standards of quality in all outputs
• Contribute to communication and change management activities associated with process initiatives

Apply below at your earliest convenience. Any questions can be directed to [email protected] or [email protected]. Please note that due to GDPR we cannot accept any CVs or applications via e-mail.