Regulatory Affairs Specialist - Animal Health (Austin, TX) at Thermo Fisher Scientific

Austin, Texas, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Animal Health, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s degree in life sciences, bio-engineering or related science
2-4 years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs, including a combination of Animal Health VDx, US IVD, and CE-IVD experience
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
Ability to work in-office in Austin, TX for 50% of the time

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
Define and implement regulatory strategy
Provide regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities

Skills

Regulatory Affairs

USDA submissions

Animal Health regulations

Regulatory strategy

Post-market surveillance

Regulatory compliance

Document compilation

Regulatory guidance

RA training

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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