At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

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 equivalent1-3 year previous work experience in the pharmaceutical industry in a data management or regulatory roleEnglish 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 advantageFoundation level in PowerBI or Power Automate  Good knowledge of company policies and procedures in Regulatory Affairs and maintenanceExcellent oral and written communication skillsDemonstrated cross-functional communication, interpersonalAbility to focus on problem solvingAbility to work within a global team framework and a multi-cultural environment  YOUR APPLICATION   

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. 

Bayer offers the possibility of working in a hybrid model. We know how important work-life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager.
Bayer respects and applies the Whistleblower Act in Poland.

     Location:Poland : Pomorskie : Gdańsk    Division:Enabling Functions   Reference Code:844817   

 

 

Location:

Poland : Pomorskie : Gdańsk  

 

Division:

Enabling Functions 

 

Reference Code:

844817