Regulatory Affairs Manager* – #01SO3
We are seeking a highly talented Regulatory Affairs Manager for current and future openings in St. Louis, MO. Our Regulatory Affairs Managers provide leadership across a diverse range of regulatory functions. The position will work across our matrix R&D environment with teams in Legal, Global Regulatory and Stewardship, as well as engaging with commercial and Technology Development teams in North America. This role will focus on developing methods and conducting pesticide residue analysis in various matrices (soil, water, plant, and animal), processing samples for mass spectral analysis, operating liquid chromatography or gas chromatography mass spectrometers, and trouble-shooting technical issues. Key Responsibilities:Leading and supporting submitting, obtaining and maintaining regulatory approvals, in collaboration with colleagues in the Global Regulatory organization.Leading and participating in cross-functional product teams to develop and execute robust strategies for regulatory submissions and product approvals for products from a diverse and expanding agrochemical and agrobiological portfolio. Interfacing across functional areas within a matrix organization including Global Regulatory Affairs, Regulatory Sciences, Regulatory Policy and Scientific Affairs, Stewardship, Law / Intellectual Property, R&D, Corporate Affairs, Technology Development, Product Supply and Quality, and the Commercial Business. Providing input on regulatory sciences strategy and preparing regulatory submissions including compiling submission materials, authoring, monitoring and coordinating responses to questions from regulatory authorities to obtain regulatory approvals in support of product launches in key markets. Developing and reviewing documents and associated processes (such as dossier templates, position statements, marketing materials, product labels, and document management). Independently keeping abreast of regulatory procedures and changes. Advising the business on timeframes, costs and work involved in new registrations, labeled use expansions, geographic expansions, product registration defenses, Data Call-Ins, and import tolerances, etc. Meeting with regulatory agencies to accomplish goals and directing interactions with regulatory agencies.Working with legal teams on product defense. Traveling independently both domestically and internationally up to 20%. Qualifications:Required Skills/Experience:Minimum of Bachelor???s degree in Chemistry, Crop Science, Toxicology, Ecotoxicology, Agronomy, Biochemistry, Bioscience Engineering, Entomology, Microbiology, Molecular Biology, Genetics, Plant Breeding, Plant Pathology, or related scientific discipline. Minimum of three or more years of relevant experience in Regulatory/Government/Industry Affairs in the agricultural, biotechnology, pharmaceutical or related scientific-based industry. Prior experience working with government agencies. Minimum of two or more years of prior experience successfully driving projects from inception to completion to meet shifting needs and/or developing and executing strategic plans. Strong written and oral communication and organizational skills, with a proven ability to convey complex ideas in a clear, precise, and actionable manner. Ability to successfully interact with diverse people and teams and continually build partnerships. Track record of leading projects through influence while building stakeholder alignment. Desired Education and Skills/Experience:Ph.D. or Master???s degree in Chemistry, Crop Science, Toxicology, Ecotoxicology, Agronomy, Biochemistry, Bioscience Engineering, Entomology, Microbiology, Molecular Biology, Genetics, Plant Breeding, Plant Pathology, or related scientific discipline. Prior experience working for a global organization. Knowledge of and experience with regulatory processes for agrochemical, agrobiological, and/or agricultural biotechnology products. Working knowledge of: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Food Quality Protection Act (FQPA), Federal Food, Drug, Cosmetic Act (FFDCA), Administrative Procedures Act (APA), US State/Territory regulations for pesticides and microbials, TSCA and/or REACH regulations. Prior experience coordinating scientists during study process, and with regulatory applications, renewals, regulatory reviews, data call-in procedures, public comments, petitions and/or legal challenges. Prior experience as a company representative on an industry association working team. Track record of successful interactions with regulatory governing bodies and/or agencies. Prior experience supporting cross-functional product development and/or launch teams for Crop Protection products and/or Seed Applied Solutions. Bayer successfully completed the acquisition of Monsanto in June 2018, bringing together Monsanto???s leadership in seeds and plant traits with Bayer???s leadership in chemical and biological crop protection. By joining forces, we will create even more extensive career opportunities for talent around the world. We???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.Apply for this job.