Senior Regulatory Affairs Specialist - Animal Health

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Job Details Senior Regulatory Affairs Specialist
- Animal Health Join a growing regulatory consulting team supporting innovative animal health products across the U.S. market.

We are seeking a seasoned Senior Regulatory Affairs Specialist
- Animal Health to provide hands‑on regulatory execution and operational support for animal health biological and pharmaceutical products. This is an exciting opportunity for a regulatory professional who enjoys working across the full product lifecycle and partnering with cross‑functional teams to deliver compliant, timely, and high‑quality regulatory outcomes. This role will initially support the BI Vet Animal Health account, with the opportunity to expand into broader Animal Health and U.S. Regulatory consulting projects as business needs evolve.

The Senior Regulatory Affairs Specialist is responsible for supporting U.S. regulatory affairs activities across product lifecycle management, regulatory submissions, labeling, product stewardship, regulatory operations, and compliance. This role is ideal for someone who brings strong execution skills, sound regulatory judgment, and the ability to manage multiple priorities in a client‑focused environment.

You will work closely with internal and client stakeholders across Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams to help ensure regulatory objectives are delivered efficiently and compliantly.

• Support regulatory lifecycle activities for animal health biologics and pharmaceutical products
• Prepare, coordinate, and maintain regulatory submissions, product registrations, and related lifecycle documentation
• Support labeling strategy execution, review, and implementation activities
• Maintain accurate regulatory documentation, records, and submission tracking
• Support product stewardship and broader regulatory operations activities
• Coordinate annual reports, post‑approval changes, and ongoing compliance activities
• Partner cross‑functionally to support the timely delivery of regulatory milestones
• Provide support for additional U.S. Regulatory consulting projects as business needs grow and shift

• Bachelor’s degree in a scientific discipline or related field
• 5 to 10+ years of experience in regulatory affairs or regulatory operations
• Experience supporting Animal Health, biologics, vaccines, pharmaceuticals, or related regulated products
• Familiarity with USDA‑CVB and/or FDA‑CVM preferred, but not required
• Strong organizational skills with exceptional attention to detail
• Excellent written and verbal communication skills
• Proven ability to manage multiple projects, deadlines, and competing priorities
• Ability to work independently while collaborating effectively with cross‑functional teams

This is more than a traditional regulatory role. It is an opportunity to join a dynamic consulting environment where your expertise will support meaningful animal health programs and where your scope can grow over time. If you are looking for a role that offers variety, visibility, and the chance to make an impact across multiple regulatory initiatives, this could be a strong next step in your career.

You are a proactive, solutions‑oriented regulatory professional who enjoys balancing detail‑oriented execution with cross‑functional collaboration.…