YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Regulatory Affairs Specialist, are to: 

• Interact with and influence internal functional technical experts to ensure the necessary scientific data, studies, documentation, interpretations and information are available in a timely manner;
• Work with technical experts, business, product safety, state affairs and others, formulate regulatory strategies to obtain favorable registrations, to defend existing product registrations, and to align with business strategic plans;
• Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings, advising on appropriate data generation, negotiation of requirements, labeling and risk mitigation;
• Plan, coordinate and prepare registration applications, scientific documents and information for new products, additional crops, new or revised use patterns, data call-ins, special reviews, and petitions for tolerances;
• Interact with regulatory agencies to obtain timely approval of pending petitions, applications and actions;
• Maintain knowledge of current pesticide regulations and contact with key regulatory authorities;
• Ensure that product-labeling claims are correct and current;
• Review Bayer Crop Science (BCS) advertising, label information, etc., for accuracy and regulatory compliance;
• Coordinate regulatory activities with The North American Free Trade Agreement (NAFTA), global, ES and other product business units to obtain consistent and harmonious regulatory approaches to maximize effectiveness and minimize costs for BCS;
• Represent BCS in industry trade association or work group activities as required.
   

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 of Science degree with at least four years of experience in regulatory registration submission environment or Master of Science degree with at least two years of experience in regulatory registration submission environment or Ph.D. with experience in regulatory registration submission environment;
• Developed written and oral communication skills;
• Ability to work well with others and in a team environment and to lead teams and projects.

Preferred Qualifications:

• Bachelor of Science with degree concentration in health, physical or natural science with at least four years of experience OR Master of Science with degree concentration in health, physical or natural science with at least two years of experience or Ph.D. with at least one year of experience with degree concentration in health, physical or natural science;
• Federal Registration Submission experience;
• Knowledge of Environmental Protection Agency (EPA) pesticide regulations and submission requirements, specifically 40 Code of Federal Regulations (CFR) part 158;
• Ability to construct persuasive scientific documents to support/defend registrations;
• Proficiency and experience in negotiation and influencing others without direct line supervisory authority;
• Scientific knowledge of applicable area(s) to the regulatory process, and basic understanding of the agriculture industry and business.