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Elanco

Making life better for animals, makes life better.

Senior Scientist, Global Regulatory Lead

ComplianceComplianceFull TimeRemoteSeniorTeam 5,001-10,000Since 1954H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

2 days ago

Salary

$118K - $197K / year

Seniority

Senior

Postgraduate Degree10 yrs expEnglish

Job Description

Senior Scientist, Global Regulatory Lead

Elanco

• Guide the design and development of the global regulatory strategy for development projects • Serve as the dedicated regulatory subject matter expert on development teams • Act as the primary point of contact for and lead direct engagements with regulatory agencies • Partner with R&D to develop and implement clinical trial submission plans • Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions • Proactively identify and communicate project-specific regulatory risks and opportunities

Job Requirements

  • A Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field
  • At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary pharmaceuticals
  • Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM)
  • Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment
  • Exceptional communication, negotiation, and influencing skills

Benefits

  • Multiple relocation packages
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
  • 8-week parental leave
  • 9 Employee Resource Groups
  • Annual bonus offering
  • Flexible work arrangements
  • Up to 6% 401K matching

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