Regulatory Information Management Specialist - #01TEV

We are seeking highly motivated Regulatory Documentation Specialists for current and future roles to join the Regulatory Affairs Team.

In this role, you will support the development and implementation of regulatory processes, compilation of product dossiers, agency submissions, and will contribute to efforts to obtain and maintain U.S. and global regulatory approvals for agrochemicals, biologs and/or biotechnology derived products across our robust pipeline and business units. You will work closely with colleagues as new products are handed-off to regulatory, fully-characterized to ensure product safety, and ultimately commercialized for sale and distribution.

This position will work in a cross-functional capacity to implement approval strategies to obtain both U.S. and international regulatory approvals. The position will utilize your document management skills, keen eye for quality, and strong process orientation to provide input on regulatory dossiers, and prepare documents to support product registrations in the U.S. and other countries., Support global regulatory strategies for our products in collaboration with colleagues in the global Regulatory organization Provide input and coordination in information management for Regulatory Affairs. Manage regulatory documentation processes to ensure that appropriate national (e.g., USDA, EPA, FDA), State/Territory, and international data (e.g., CODEX, OECD) requirements are met Assist in the preparation of regulatory submissions, edit submissions, coordinate responses to questions from regulatory authorities, develop product composition statements, certificates of origin, production reports, develop product labeling, and support the development of other related documents (e.g., white papers, position statements, etc) to obtain regulatory approvals in the US and other markets Improve internal regulatory processes and manage information databases Filing, archiving, uploading and viewing Regulatory documents

Minimum of a Bachelorâ??s degree, or professional degree equivalent through experience One or more years of relevant experience in the agricultural, chemical, biotechnology, pharmaceutical or related scientific based industry Excellent written/oral communication and organization skills Proficient with IT tools and databases, and mastery of Microsoft Office suite of applications Strong project management skills, and the ability to successfully interact with a wide diversity of people Desired Skills/Experience:

Prior experience working for a life sciences company Prior experience working in a regulated environment for biological, agrochemical, chemical, biotechnology, or pharmaceutical products

Bayer successfully completed the acquisition of Monsanto in June 2018, bringing together Monsantoâ??s leadership in seeds and plant traits with Bayerâ??s leadership in chemical and biological crop protection. By joining forces, we will create even more extensive career opportunities for talent around the world. Weâ??re a global team working to shape agriculture through breakthrough innovation that will benefit farmers, consumers, and our planet.

While we are now Bayer, we will continue to hire using separate career sites until we can integrate our career platforms. We invite you to explore the career opportunities available at the combined company by visiting advancingtogether.com/careers.