Monsanto Regulatory Affairs Specialist in ST. LOUIS, Missouri
We are currently seeking a highly motivated individual to join the Global Chemistry and Seed Regulatory Affairs on as a Regulatory Affairs Specialist . The Global Chemistry & Seed Regulatory Affairs organization is accountable for obtaining and maintaining chemistry, biologicals, and seed regulatory approvals, and works in partnership with others to support freedom to operate (FTO) for our expanding global Ag productivity and Seeds businesses. The focus for this Regulatory Affairs Specialist role will be oversight, planning and hands on management of submissions to meet filing deadlines at the global, federal and/or state level. This will include managing and tracking the delivery of regulatory submission components to meet regulatory and commercial deadlines, as well as to ensure proper archiving of all submission documents.
We seek a candidate whose knowledge of regulatory requirements and practices is complemented by superb organizational skills, a keen eye for detail and the ability to move the process forward, while ensuring deadlines and standards are met. This individual will be responsible for the compilation and submission of registration documents, to adhere to internal and external compliance processes, ensure the tracking of registrations and requirements, communicating approvals to stakeholders, and engaging in efforts to increase the efficiencies of the submission process. The Regulatory Affairs Specialist will work closely with Regulatory Affairs Managers and other team members to ensure a robust regulatory strategy is developed and implemented in anticipation of any special compliance needs or procedures, and that any product labeling is suitable for submission.
The position is part of a fast-paced, timeline-driven, project-managed, team-oriented environment that requires collaboration on group based projects. The role will be in St. Louis, MO.
Implementing US and/or Global regulatory submission and approval strategies in collaboration with colleagues in the Global Regulatory Organization.
Supporting the Regulatory Affairs Manager on the planning and implementation of efforts to obtain new registrations, labeled use expansions and geographic expansions, product registration defense, Data Call-Ins, import tolerances, etc.
Providing input on regulatory study plans to ensure that appropriate national and/or international data requirements are met, and monitor progress in accordance to project plans.
Drafting, preparing, compiling, coordinating, and filing regulatory submissions and labels in accordance to agency procedures and requirements.
Drafting and coordinating responses to questions from regulatory authorities to obtain regulatory approvals in support of product launches in key markets.
Developing, implementing, and monitoring plans and timelines.
Developing and reviewing documents and associated processes, such as dossier templates, position statements, marketing materials, product labels, document management, and project management.
Staying abreast of regulatory submission procedures, agency requirements and changes in data requirements and procedures.
Acting independently to anticipate needs, studying issues, identifying options, and offering compliance solutions. Reviewing regulatory and compliance requirements, agency documents, case history, and product profiles.
Reviewing and researching specific issues, requirements, strategies, scenarios, products or procedures, to inform the regulatory strategy, create break-throughs, and accomplish goals.
Preparing documents, summaries, and presentations to senior leadership and regulatory agencies to accomplish goals. Compiling, researching, managing and archiving information.
Building effective relationships with key stakeholders, ensure effective communication, information flow, and effective issue resolution.
Collaborate and facilitate collaborations across multiple teams.
Organizing meetings, and coordinating or leading the activities of others.
Domestic travel estimated at 10% of time.
Required Education and Skills/Experience:
Minimum of a Bachelor’s Degree in Crop Science, Genetics, Plant Breeding, Biochemistry, Chemistry, Biology, Agriculture, Biotechnology, Protein Chemistry or related scientific discipline.
Minimum of three or more years of relevant experience in the agricultural, biotechnology, Regulatory/Government/Industry Affairs, pharmaceutical or related scientific based industry (in industry or academia).
Strong written and oral communication and organization skills, with a proven ability to convey complex ideas in a clear, precise, and actionable manner.
Ability to drive and manage projects cross-functionally and develop/execute strategic plans.
Strong team skills and ability to work in a matrix environment.
Ability to identify, respond and independently work through varying requirements and/or demands relating to internal/external customers, regulators and legislative changes that impact product portfolio.
Strong results orientation, and attention to detail and quality.
Proficient in the Microsoft Office suite of software applications.
Desired Education and Skills/Experience:
PhD or Master’s Degree in Crop Science, Genetics, Plant Breeding, Biochemistry, Chemistry, Biology, Agriculture, Biotechnology, Protein Chemistry or related scientific discipline.
Five or more years of experience with agrochemicals and/or agricultural biotechnology derived products.
Five or more years of experience dealing with regulated material, regulatory agencies and/or compliance.
Successful track record of building and managing regulatory submissions through regulatory review processes.
Experience with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Food Quality Protection Act (FQPA), Federal Food, Drug, Cosmetic Act (FFDCA) in the United States, OECD, CODEX, TSCA, and/or REACH regulations.
Experience with FIFRA label elements (signal words, precautionary language, personal protective equipment, mandatory label language).
Two or more years of global experience in a Regulatory position.
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.
Organization: Global Chemical Regulatory Affairs51096759_
Title: Regulatory Affairs Specialist
Location: North America-USA-Missouri-St. Louis
Requisition ID: 01TET
Job: Research & Development
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