Regulatory Affairs Manager-000KA

Description

The U.S. Biotechnology Regulatory Affairs Team is seeking a Regulatory Affairs Manager who will support the development and implementation of regulatory strategies, product dossiers, agency submissions, and will lead efforts to obtain and maintain U.S. and global regulatory approvals for Monsanto's agricultural biotechnology-derived products, such as corn, cotton, soybean, and specialty crops. The successful candidate will work closely with colleagues as new products are handed-off to regulatory, fully-characterized to ensure product safety, and ultimately commercialized for sale and distribution. This role works in close coordination with many functional areas within a matrix organization including Discovery, 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 build and implement approval strategies to obtain both U.S. and international regulatory approvals, use their scientific/technical background to provide input on regulatory reports, and prepare documents to support product registrations in the U.S. and other production and key export countries.

· Key Deliverables:

o Provide the leadership and delivery of global regulatory strategies for Monsanto's products in collaboration with colleagues in the global Regulatory organization;
o Provide input and guidance in regulatory study reports to ensure that appropriate national (e.g., USDA, EPA, FDA) and international data (e.g., CODEX, OECD) requirements are met;
o Prepare regulatory submissions, coordinate responses to questions from regulatory authorities, and develop other related documents (e.g., white papers, position statements, etc.) to obtain regulatory approvals in key export and production countries; and
o Collaborate with the business teams on the identification, implementation, and management of regulatory acceptance and stewardship issues.


Qualifications

An advanced degree (MS/Ph.D.) or relevant experience in one of the biological/chemical sciences and excellent written/oral communication and organization skills are required. The successful candidate must be able to take the initiative in a team-based environment to lead teams and organize data and information effectively, write clear and convincing documents, work with customers to meet timelines and needs, demonstrate effective negotiation and persuasive skills, employ project management skills, and have the ability to successfully interact with a wide diversity of people and government agencies. Detail-oriented and self-motivated individuals with experience in agricultural biotechnology, biology, biochemistry, molecular biology, protein chemistry, agronomy, quality assurance, and/or regulatory are preferred. Experience and/or an understanding of regulatory processes for biotechnology products and interactions with key global regulatory governing bodies/agencies are considered valuable assets for this position.

Job
Research & Development
Primary Location
North America-USA-Missouri-St. Louis
Organization
Global Regulatory Affairs_51013075
Schedule
Full-time