Regulatory Submissions Manager-000LA

Description

The Global Regulatory Submission Center Team is seeking a Regulatory Submission Manager who will support the development and implementation of regulatory submission strategies, the writing and reviewing of product dossiers, and who will facilitate the completion of product-specific global safety summaries to support global regulatory submissions in the U.S., other key production countries, and their export markets, as part of the U.S. Biotechnology Regulatory Affairs Team. The successful candidate will support efforts to obtain U.S. and international regulatory approvals for Monsanto's agricultural biotechnology-derived products, such as corn, cotton, soybean, and specialty crops, by assuring the development of consistent and high quality dossiers for all crop registrations while working in close partnership with the U.S. and international Regulatory Affairs Managers. This individual will also work closely with U.S. and international Regulatory colleagues to develop and implement processes and improvements to produce high quality dossiers, and more efficient dossier development and review processes across the Global Regulatory organization.

The Regulatory Submissions Manager will work in close coordination with individuals across many functional areas of a matrix organization including Biotechnology, Global Regulatory Affairs, Pipeline Regulatory, Regulatory Technology Centers, Project Management, Crop Teams, Breeding, Industry Affairs, Public Affairs, U.S. Markets, Legal, and Trait Stewardship. This individual will work in a cross-functional capacity to create and implement dossier development and review strategies, as well as improvements in the areas of data analyses and strategic presentation of data to ensure both U.S. and international regulatory approvals. He/she will also lead continuous process improvement efforts that contribute to higher quality dossiers and a more efficient dossier submission process, as well as to improved operational capacity within Regulatory Affairs. This individual will use his/her scientific/technical background and expertise to write and provide input to facilitate the completion of regulatory dossiers, and will be responsible for assuring effective preparation of submission documents to support global product registrations.

Key Deliverables:

• Provide leadership to assure delivery of high quality dossiers for global regulatory submissions in support of Monsanto's biotechnology product approvals in collaboration with colleagues in the global Regulatory organization
• Provide input into the planning and coordination of regulatory studies to help ensure that appropriate national (e.g., USDA, EPA, FDA) and international data (e.g., Codex, OECD) requirements are met, and that the data are incorporated into dossiers in a manner suitable for global use
• Prepare product-specific global safety summaries to support U.S. and international regulatory submissions, support development of responses to questions from regulatory authorities, and develop an efficient submission process to obtain regulatory approvals in key export and production countries
• Develop and facilitate processes to improve writing and review of dossiers
• Use scientific and technical expertise to write and edit regulatory dossiers to assure the timely review and approval of products.

Qualifications

An advanced degree (MS/Ph.D.) or several years of relevant experience in one of the biological/chemical sciences and excellent written/oral communication and organization skills are required. Knowledge and experience in molecular biology is required, and knowledge of plant physiology and/or genetics is highly desirable. Experience in the area of biotechnology crop traits with strong technical background in biotechnology skills is also desirable. The successful candidate must be able to take the initiative in a team-based environment to lead teams, organize data and information effectively, and to write clear and convincing documents. Other critical skills for success include having the ability to work with stakeholders to meet timelines and needs, demonstrating effective negotiation and persuasion skills, employing project management skills, and having the ability to interact in a diverse environment, across cultures and with government agencies. Detail-oriented and self-motivated individuals with experience in agricultural biotechnology, biology, biochemistry, molecular biology, protein chemistry, agronomy, and/or a regulatory environment are preferred.

Experience with and an understanding of regulatory processes for biotechnology products and key global regulatory governing bodies and agencies are highly desirable

This position may require occasional travel


Job
Research & Development
Primary Location
North America-USA-Missouri-St. Louis
Organization
Global Regulatory Strategy & Ops_51012893
Schedule
Full-time