Thermo Fisher Scientific

Regulatory Affairs Specialist III, Animal Health

Thermo Fisher Scientific$80K — $100K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences, bio-engineering, or related science required.
  • 2+ years of experience in Animal Health Diagnostic or Human IVD Regulatory Affairs, including USDA regulations.
  • Experience with regulatory permits and licenses.
  • Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.
  • Expertise in regulatory strategy creation and development control.

Responsibilities

  • Write and submit regulatory documents to agencies, primarily the USDA.
  • Communicate with regulators, addressing questions and discussing submissions.
  • Serve as a subject matter expert in Animal Health regulations and competitor news.
  • Coordinate the resolution of regulatory issues using various resources.
  • Conduct training to enhance team understanding of regulatory environments.
  • Review labeling, packaging, and promotional materials for compliance.
  • Collaborate with global regulatory professionals on strategies and submissions.

Benefits

  • Relocation assistance offered.
  • Competitive remuneration and annual incentive plan bonus.
  • Comprehensive healthcare and employee benefits package.
  • Opportunities for career and development growth.
  • Dynamic company culture emphasizing integrity, intensity, involvement, and innovation.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position is in an office setting and follows a typical Monday-to-Friday work schedule.

We offer relocation assistance!

Discover Impactful Work

Join us to help build the future of science and healthcare by ensuring regulatory compliance in our innovative Animal Health product lines. 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.

A day in the Life
  • 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.


Keys to Success

Education
  • Bachelor's degree in life sciences, bio-engineering or related science required.


Experience
  • 2+ years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health VDx as well as US IVD and CE-IVD experience required.
  • Experience working with USDA regulations required.
  • Demonstrated ability to maintain regulatory permits and licenses.
  • Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.


Knowledge, Skills, Abilities
  • 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.


Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

Similar Jobs

More Jobs at Thermo Fisher Scientific

More Pharmaceuticals & Biotech Jobs

Find similar Regulatory Affairs Specialist III, Animal Health jobs: