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Compliance Support Expert 

Role's Purpose:

Support global RA business function with implementation of regulatory activity related data (applications, registrations, global and local variations etc) within the Regulatory Information Management system (Veeva Vault RIM) and thereby serves RA, other CH and R&D functions and Product Supply to reach business goals and to ensure regulatory compliant life cycle management of the product portfolio.

Contribute to develop further the global integration of regulatory related key data in close cooperation with the relevant RA functions to achieve a mid to long term optimization of the integrated system, process and data landscape. 
 

Your Tasks & Responsibilities
 

Support Regulatory Operations and Automation Organization to achieve RA objectives:
 

• Create MasterData records and maintain an integrated tracking data base system within an integrated system landscape containing key data on regulatory events and the documentation submitted in each country;
• Support a global tracking system and provide the related reporting and business intelligence capabilities, provide RA data to effectively run the RA business and keepRA business compliant with requirements of Health Authorities;
• Support global communication (across functions and locations) for tracking regulatory processes and issues; provides training for end users of the tracking system;
• SupportRIM Process owners and SMEs on global level discussion and actions.
   

Who You Are:

• MS degree in life sciences or Bachelor Degree in Pharmaceutical or related Sciences or equivalent
• 1-3 year previous work experience in the pharmaceutical industry in a data management or regulatory role
• English at least C1 written and spoken 
• Intermediate Microsoft Office (e.g Excel) 
• Intermediate knowledge and experience in usage of digital collaboration tools (e.g Teams, SharePoint) 
• Veeva Vault RIM knowledge will be a strong advantage
• Foundation level in PowerBI or Power Automate  
• Good knowledge of company policies and procedures in Regulatory Affairs and maintenance
• Excellent oral and written communication skills
• Demonstrated cross-functional communication, interpersonal
• Ability to focus on problem solving
• Ability to work within a global team framework and a multi-cultural environment

Location:

Poland : Pomorskie : Gdańsk  

Division:

Enabling Functions 

Reference Code:

844817