Regulatory Affairs Specialist Iii, Animal Health

PPD (Thermo Fisher) UK

Austin, Texas, United States
On-site
Define and implement regulatory strategy
Provide regulatory guidance
Post-market surveillance and compliance
The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities

Job Summary

  • The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
  • Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio.
  • We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Matching Summary

The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.

Skills & Requirements

Must-have

  • define and implement regulatory strategy
  • provide regulatory guidance
  • post-market surveillance and compliance
  • write and submit regulatory documents
  • engage regulators in communication
  • Animal Health regulations
  • review labeling and promotional materials

Nice-to-have

  • develop solutions for tough challenges
  • positive impact on a global scale
  • innovative, forward-thinking organization

Key Requirements

  • Bachelor’s degree in life sciences, bio-engineering or related science
  • 2+ years of experience in Animal Health Diagnostic or Human IVD Regulatory Affairs
  • Experience working with USDA regulations
  • Demonstrated ability to maintain regulatory permits and licenses
  • Proficiency in preparing regulatory compliance reports

Work Rights

Not specified

Tailored Resume

Cover Letter