Thermo Fisher Scientific · 2 days ago
Regulatory Affairs Specialist - Animal Health (Austin, TX)
Austin, TX
Full-time
Hybrid
Entry, Mid Level
2+ years expThermo Fisher Scientific is dedicated to making a positive impact on a global scale, and they are seeking a Regulatory Affairs Specialist III to ensure regulatory compliance for their Animal Health product lines. The role involves defining and implementing regulatory strategies, providing guidance to product development teams, and engaging with regulators to facilitate submissions and compliance activities.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio
Engage regulators in oral and written communications to discuss submissions, requirements, and address questions
Serve as RA subject matter expert, staying current on Animal Health regulations, guidance documents, notices, and competitor news
Coordinate regulatory issue resolution using internal resources, agencies, and outside consultants
Conduct trainings and communicate materials to enhance team knowledge of regulated environments
Review and approve labeling, packaging, advertising, and promotional materials for regulatory compliance
Participate in business meetings with internal collaborators and external partners
Collaborate with global regulatory professionals, providing guidance on strategies, submissions, and projects
Qualification
Required
Minimum requirement of a Bachelor's degree in life sciences, bio-engineering or related science
A minimum of 2-4 years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs
Demonstrated ability to maintain regulatory permits and licenses
Proficiency in preparing regulatory compliance reports and performing regulatory surveillance
Experience in regulatory affairs, including strategy creation and development control
Outstanding attention to detail and time management skills
Excellent interpersonal, customer orientation, and presentation skills
Provided regulatory guidance on project teams
Detail-oriented for regulatory reviews
Skilled in multi-tasking and business impact
Effective in matrixed environments and conflict resolution
Preferred
Experience in Animal Health Diagnostic
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
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2025-12-31
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2025-12-19
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