Senior Regulatory Label Specialist - Crop Science

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Senior Regulatory Label Specialist - Crop Science

YOUR TASKS AND RESPONSIBILITIES

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

• Manage assigned product labels ensuring compliance with EPA and state regulations with respect to correct/accurate labeling language;
• Ensure compliance with the labeling change management process;
• Maintain a high standard of accuracy and timeliness to support the Business Objectives to achieve registrations according to timeline;
• Create US product labels for federal and state submission in collaboration with Registration, Development, Marketing, and or Legal;
• Identify proactively and correct errors in labels to mitigate potential compliance issues;
• Propose appropriate label language that will cause the least disruption to the business;
• Lead multiple cross-functional projects of medium to high complexity in the area of label management or process improvements;
• Serve as BCS representative for labeling, documentation, and electronic submission topics for U.S. and Global on internal and external task forces, Industry committees, and projects;
• Review and approve labels to be posted on BCS-selected external online sites;
• Create and maintain label records in internal company label databases for access and use by BCS employees;
• Conduct periodic audits of labels to ensure the most current and correct label is on file;
• Coordinate with Graphics Labelling team in providing regulatory text for production labels according to manufacturing/production needs;
• Serve as the contact person for international certificate requests;
• Obtain Gold Seal Letters from EPA and Creates international certificates (such as authorization letters, certificates of Analysis, certificates of composition, certificates of origin, certificates of exportation, manufacturing certificates, and various others) for our international counterparts ensuring the appropriate certifications and authentications are obtained;
• Ensure timely completion of each document request and accurate response to corresponding countries for all requests;
• Ensure labeling information in regulatory systems is current and correct on relevant product use information as labels are approved;
• Create and files purchase agreement documents required for shipment of products across borders in the specified databases;
• Maintain current awareness of, and ensure company compliance with, evolving regulatory label requirements, including implementing label language changes;
• Participate actively in business team meetings to develop strategies to comply with upcoming label requirements;
• Participate in the industry plus authority meetings and initiatives related to label content improvements or management;
• Communicate developments and ramifications to internal stakeholders;
• Be recognized as an expert in federal and state label requirements;
• Be capable of proposing and leading internal BCS or external industry initiatives related to label content improvements or management (e.g. SMART label.);
• Provide mentoring to colleagues within the area of expertise;
• Develop and deliver training and work instructions on labeling end-to-end process and label management systems focused on new members and RS teams within North America;
• Share relevant knowledge, insights, and experience with colleagues
• Proactively Identify process improvements and drive implementation of technological solutions to gain process efficiencies.

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
• Demonstrated extensive knowledge and understanding of the Regulatory domain, Agricultural industry, and competitive landscape;
• Demonstrated extensive knowledge and understanding of relevant labeling regulations and compliance as well as federal and state labeling requirements;
• Extensive experience with Document management systems as well as Document creation and editing tools;
• Highly skilled at identifying recognizing potential labeling compliance issues and proactively proposing mitigating solutions;
• Demonstrated ability to proactively escalate any timeline concerns, risks, and issues that may delay/impact assignments and engage appropriate stakeholders to manage outcomes
• Demonstrated excellent verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization;
• Ability to maintain open communication with customers and builds sustainable relationships;
• Skilled at leveraging Data and Technology to deliver performance improvements and gain efficiencies;
• Demonstrated ability to act in a speedy and pragmatic manner, adapts quickly to changing environments, without sacrificing quality and long-term goals;
• Expert at time management, meeting deadlines, and assessing juggling shifting priorities in a rapid-pace environment;
• Excellent attention to detail and organizational skills;
• Highly Skilled at problem-solving and finding solutions;
• Ability to Lead multiple cross-functional projects of medium complexity;
• Skilled at developing training materials and conducting training on processes, systems, and tools;
• Represent RA in meetings (internally and externally) with senior management and peers;
• Represent BCS and lead label-specific workgroups in state-level industry associations;
• May represent BCS on certain federal labeling industry task forces;
• Able to reduce complexity within the area of responsibility;
• Ability to mentor and coach junior colleagues;
• Able to work independently with minimal supervision.

Preferred Qualifications:

• Bachelor's degree with 5 years of relevant experience
• Master's degree with 3 years of relevant experience;
• Ph.D. with at least 1 year of relevant experience;
• Degrees in agriculture, physical science, or natural science;
• Relevant experience in the agricultural and or regulatory domain.

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