Regulatory Affairs Intern

Phibro Animal Health Corp
  • Teaneck, NJ
    30+ days ago

    Job Description

    About Phibro Animal Health Corporation

    Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

    Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro's revenues are in excess of $1 billion and are supported by over 2,400 employees worldwide.

    At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

    If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.

    The Regulatory Affairs Intern is an integral part of our Regulatory Affairs team based out of our US - Teaneck, NJ - Remote site.

    Position Details

    The Regulatory Affairs Intern will support the Animal Health Regulatory Affairs team by learning the regulatory pathways and sponsor obligations associated with new animal drug development and approval. This role provides hands-on exposure to regulatory strategy, dossier assessment, study oversight requirements, procedural document writing, and document organization in support of future system migration activities.

    Key Responsibilities

    • Learn the regulatory framework for new animal drug approvals, including core submission components and health authority expectations.
    • Review and summarize dossier content, technical data, and supporting documentation
    • Assist with background research on MUMS criteria
    • Support the team in understanding sponsor obligations for oversight of nonclinical and clinical studies conducted in accordance with GLP and GCP principles.
    • Draft, revise, and format procedures, work instructions, and other controlled documents associated with study oversight and regulatory operations.
    • Organize, index, and maintain FDA regulatory correspondence and related records to support retrieval, inspection readiness, and later migration into Veeva.
    • Collaborate with Regulatory Affairs and cross-functional colleagues to compile information, clarify data sources, and support project deliverables.

    Key Competencies

    Accepting Direction

    Adaptable

    Attendance and Punctuality

    Attentive Listening

    Collaborative

    Communicating Effectively

    Critical Thinking

    Demonstrating Initiative

    Demonstrating Tenacity and Perseverance

    Detailed Oriented

    Establishing Relationships

    Following Policies and Procedures

    Learning Quickly

    Managing Time

    Prioritizing and Organizing Work

    Problem Solving

    Skills

    Proficiency in Microsoft Office Products

    A motivated self-starter, work well in groups and demonstrate excellent customer service.

    Excellent Written and Verbal Communication Skills

    Education & Experience

    • Currently pursuing a bachelor's, master's, or professional degree in veterinary science, animal science, biological sciences, regulatory affairs, public health, or a related discipline.
    • Strong interest in animal health product development, regulatory science, and FDA submission processes.
    • Excellent written communication skills, with the ability to summarize complex scientific and regulatory information clearly and accurately.

    Physical Requirements

    Good hand/eye coordination

    Required to talk or hear frequently

    To learn more about Phibro Animal Healths competitive benefits package, please click here: Phibro Benefits

    Phibro is an Equal Opportunity Employer

    All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

    Business Unit: Animal Health & Mineral Nutrition

    Division: Animal Health & Nutrition

    Department: Regulatory Affairs

    Location: US - Teaneck, NJ - Remote

    Work Schedule: Monday - Friday (Standard Work hours)

    Numbers & Facts

    LocationTeaneck, NJ

    Skills

    • Animal Careunmatched
    • Animal Husbandryunmatched
    • Animal Nutritionunmatched
    • Biologyunmatched
    • Clinical Trialunmatched
    • Communication Skillsunmatched
    • Cross-Functionalunmatched
    • Customer Support/Serviceunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • Drug Developmentunmatched
    • Establish Prioritiesunmatched
    • FDA Requirementsunmatched
    • GCP (Good Clinical Practices)unmatched
    • GLP (Good Laboratory Practices)unmatched
    • Manufacturingunmatched
    • Marketingunmatched
    • Microsoft Officeunmatched
    • Microsoft Product Familyunmatched
    • Nutritionunmatched
    • Physical Demandsunmatched
    • Pre-Clinical Trialsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Product Developmentunmatched
    • Public Affairsunmatched
    • Public Healthunmatched
    • Regulationsunmatched
    • Strategic Analysisunmatched
    • Support Documentationunmatched
    • System Migrationunmatched
    • Team Playerunmatched
    • Technical Supportunmatched
    • Technical Writingunmatched
    • Vaccinationunmatched
    • Veterinary Medicineunmatched
    • Writing Skillsunmatched

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