YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Manager Global Regulatory Strategy Development, are to: 

• Contribute and support the development and execution of global Regulatory strategies;
• Co-author and prepare regulatory documents and reports including preparation and maintenance of technical files and assisting in preparation of global registration submissions;
• Support Regulatory Affairs Teams and/or Global Project Teams;
• Contribute to regulatory decisions and communications to internal/external stakeholders;
• Provide regulatory support, as required, for Regulatory strategy completion/implementation, product supply projects, advertising reviews, risk management and recalls;
• Provide preliminary evaluation of design changes;
• Work, possibly, on assigned special projects such as contributing to Regulatory Affairs functional improvement initiatives;
• Be capable of performing these tasks with moderate supervision.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor’s degree with at least 4 years of Regulatory experience; OR a Master’s with at least 2 years of regulatory experience; OR a Ph.D., M.D., P.Eng. or Pharm.D. with no regulatory experience;
• Working understanding of device regulations;
• Substantial experience with multitasking in a deadline controlled and highly regulated environment;
• Ability to communicate effectively in English both verbally and in writing;
• Team and customer orientation;
• Have results orientation;
• Demonstrate commercial orientation;
• Demonstrate ability to collaborate.

#LI-US