Regulatory Affairs Intern

Phibro•Teaneck, NJ

18h•Remote

About The Position

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.

Requirements

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.
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

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.