Job ID 4585 Company: Bayer Job Location Shawnee , KS
Manager Regulatory Affairs (Shawnee, KS)
Job RequirementsYour 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:
*B.S. degree in related science area with 12 plus years relevant experience or M.S. in related science area with 10 plus years relevant experience;
*Must have thorough knowledge of applicable federal regulations with extensive experience interacting with CVM-FDA, as well as an understanding of FDA procedures and policies;
*Must be detail oriented with strong organizational, interpersonal, and communication skills;
*Expert skill level with handling of electronic documents (e.g., Microsoft Word and Adobe Acrobat), presentation software (e.g., PowerPoint), and project timelines (e.g., Microsoft Project), along with an aptitude to learn new systems;
*Must work well in cross-functional teams that exist in the product development matrix structure in Bayer Animal Health;
*Sound decision-making capabilities;
*Must possess good skills in coordinating and influencing outcome to large regulatory projects and working with members of the regulatory
*Displayed experiences and career achievements to be assessed as capable in the areas of Managing Complexity, Collaboration, Driving for Results and Plans and Aligns;
*Willing to travel to U.S. and international locations.
*D.V.M. degree with 6 plus years relevant experience or Ph.D. degree in related area with 6 plus years relevant experience.
Job DescriptionThe primary responsibilities of this role, Manager Regulatory Affairs, are to:
^Represent the company when communicating and negotiating with FDA or other regulatory authority officials concerning requirements for obtaining approvals of submissions;
*Communicate current regulatory requirements and provide direction and insight into future requirements to project teams as well as middle and upper management;
*Maintain a current knowledge of regulatory requirements by continued review of regulations, new guidelines, and trade publications, as well as by participating in the working groups of trade associations such as the Animal Health Institute;
*Ensure that assigned projects are carried out in full compliance with government regulations;
*Maintain knowledge and skills in electronic submissions to CVM-FDA;
*Handle several continuing projects simultaneously;
*Have a direct impact on regulatory agency decisions as to whether products may be legally marketed and ensure that the regulatory aspects of these projects are completed accurately and in a timely manner;
*Track the payment of all ADUFA fees to FDA and facilitate
budgeting for the fees with R&D Administration;
*Assist activities of regulatory affairs representatives assigned to
maintenance projects when required.
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