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Regulatory Affairs Manager - Biotechnology - #00723

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Location: St. Louis, Missouri, Mid-West United States, USA
Company: Monsanto
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Open Til: 22-Mar-12
Industry Sector: Agribusiness
Industry Type: Crop Protection/Chemicals
Career Type: Researcher/Scientist
Job Type: Full Time
Minimum Years Experience Required: N/A
Salary: Competitive

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Monsanto is seeking a highly motivate individual to join The U.S. Biotechnology Regulatory Affairs Team as a Regulatory Affairs Manager.  In this role, you 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 biotechnology-derived products across Monsanto&##39;s robust pipeline and business units.  You 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. Additionally, you will work in close coordination with many functional areas within a matrix organization including Discovery, Global Regulatory Affairs, Regulatory Pipeline Strategy, Regulatory Technology Centers, Regulatory Policy and Scientific Affairs, Crop Teams, Breeding, Industry Affairs, Public Affairs, U.S. Markets, Legal, and Trait Stewardship.  You 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.
  • Provide the leadership and delivery of global regulatory strategies for Monsanto&##39;s products in collaboration with colleagues in the global Regulatory organization
  • 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
  • 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
  • Collaborate with the business teams on the identification, implementation, and management of regulatory acceptance and stewardship issues.

Required Skills/Experience:
  • A degree (BS/MS/PhD) in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry or related scientific discipline
  • A BS degree with 5+ years relevant experience, a MS degree with 3+ years relevant experience, or a PhD with 2+ years relevant experience in the agricultural, biotechnology, pharmaceutical or related scientific based industry.
  • Excellent written/oral communication and organization skills are required. 
  • 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. 
Desired Skills/Experience:
  • PhD in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry or related scientific discipline
  • Experience and/or an understanding of regulatory processes for biotechnology products and interactions with key global regulatory governing bodies/agencies