Regulatory Compliance Specialist

Summary:

Genus plc is a market leader in porcine, dairy, and beef genetics. We are uniquely positioned as a global player with a large investment in dedicated research and development.  Food consumption is expected to rise by 60% in the next 20 years. Our challenge is to affordably and sustainably meet that escalating demand while global resources diminish.  Our vision is clear: Pioneering animal genetic improvement to help nourish the world. We are seeking a Regulatory Compliance Specialist to join the Regulatory team in pioneering research to transform the global animal protein industry. 

Overview:

The Regulatory Compliance Specialist will work with Senior Regulatory Science and Compliance Manager to support compliance of porcine and bovine programs. As a member of the Regulatory team, there will be work with trait development and product development teams to maintain and enhance compliance capabilities and relationships to support Genus Product Pipeline. There will also be opportunities to help in maintaining the Genus products to meet the high standards of compliance with governmental regulatory and quality control requirements. Join our team to make a global impact on one of the biggest challenges currently facing mankind. 

Key Responsibilities: 

  • Help in compliance of Genus research and product development activities with applicable government laws and regulations and Good Laboratory Practices (GLP) standards
  • Assist on all aspects of compliance, quality control and stewardship through the discovery, development, launch and post approval stages of Genus Products
  • Help in developing reports, SOPs, trainings, audits and corrective actions for compliance with domestic (FDA/CVM and related agencies) and global regulations
  • Work with trait development and product development teams to maintain and enhance compliance capabilities and relationships to support Genus product pipeline
  • Help in maintaining the Genus products to meet the high standards of compliance with governmental regulatory and quality control requirements
  • Work with Senior Regulatory Science and Compliance Manager to support regulatory compliance of porcine and bovine programs
  • Travel 5-10%, domestically

Minimal Qualifications: 

  • BS or MS degree (Animal Sciences, Plant Sciences, Life Sciences, Biology or Molecular Biology)
  • 2-5+ years of regulatory compliance experience in life sciences – technology-driven company
  • Knowledge of GLP standards, compliance and quality control measures required for biotechnology products
  • Proficiency in use of Microsoft Project, Excel, Power Point and Word
  • Good communication and interpersonal skills 

 Preferred Qualifications: 

  • Experience on a multi-disciplinary product or technology development team
  • Demonstrated experience in project management and compliance with regulations
  • Familiarity with gene editing technology regulations for in-country production and import of biotech products 
  • Experience in interacting or working with the U.S. regulatory agencies (FDA, USDA-APHIS)

  Capabilities and behaviors: 

  • Lives and displays the Genus Values
  • Collaborates constructively with peers and team
  • Enjoys working with customers on regulatory compliance
  • Maintains professional verbal and written communications with co-workers and internal customers
  • Flexible with job responsibilities and consistently strives to be an effective team member 

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