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Veterinary Biologics Regulatory & Development Strategy Consultant

Location: Remote
Engagement Type: Consulting / Contract
Start: As soon as possible
Target Completion: By the end of 2026

Position Overview

We are seeking an experienced Veterinary Regulatory & Development Strategy Consultant to support an early-stage development program for a novel feline biologic therapeutic.

The consultant will help establish an integrated U.S. regulatory and development strategy, with particular emphasis on FDA Center for Veterinary Medicine (CVM) requirements, development planning, regulatory interactions, and the use of international CROs and foreign-generated study data.

The ideal consultant will have significant experience with veterinary drug and/or biologics development and navigating FDA CVM regulatory pathways. Former FDA experience is welcome but not required.

Key Responsibilities

FDA CVM Regulatory Strategy & Engagement

• Assess and confirm the appropriate product classification and U.S. regulatory pathway.

• Determine the appropriate regulatory authority and pathway, including FDA CVM or USDA, if applicable.

• Provide strategic guidance for establishing an Investigational New Animal Drug (INAD) file.

• Develop a phased regulatory strategy progressing toward a New Animal Drug Application (NADA).

• Advise on the timing, content, and strategy for regulatory agency interactions.

• Assess potential eligibility for conditional or expanded conditional approval and recommend an appropriate regulatory strategy.

Veterinary Development Strategy

• Review and refine the existing development package for an early-stage feline therapeutic program.

• Evaluate the proposed preclinical/nonclinical and clinical development sequence.

• Confirm that planned studies are appropriately designed to support future regulatory submissions.

• Identify scientific, regulatory, or development gaps that could impact advancement of the program.

• Review the proposed in vivo feline study strategy and assess whether the design, endpoints, and resulting data will adequately support future submissions.

• Recommend additional studies or development activities where appropriate.

• Develop an integrated roadmap connecting early development activities with future regulatory milestones.

International CRO & Foreign Study Data Strategy

• Advise on the use of international CROs for development activities.

• Assess which development activities may appropriately be conducted outside the United States, including protein production, assay development, PK/PD, safety, and clinical studies.

• Provide guidance regarding applicable GLP, GCP, data integrity, documentation, and regulatory requirements for foreign-generated data.

• Evaluate the acceptability of foreign study data for future FDA submissions.

• Determine whether U.S. bridging or confirmatory studies may be advisable or required.

• Recommend strategies for CRO qualification, oversight, documentation, and study execution to maximize regulatory acceptance of resulting data.

CRO Partnership & Development Considerations

• Provide strategic input regarding development and cost-sharing arrangements with external CRO partners.

• Advise on regulatory-development considerations associated with maintaining appropriate ownership and control of product-related intellectual property, regulatory data, and commercialization rights.

• Identify areas where specialized intellectual property or transactional legal counsel should be incorporated into the partnership strategy.

Consultant Qualifications

• Significant experience with FDA CVM regulatory strategy and veterinary drug development.

• Demonstrated knowledge of INAD and NADA regulatory pathways.

• Experience developing regulatory strategies for early-stage animal health products.

• Experience with biologics, recombinant proteins, or other complex veterinary therapeutics strongly preferred.

• Understanding of conditional and expanded conditional approval pathways for animal drugs.

• Ability to critically review preclinical and clinical development plans and identify regulatory or development gaps.

• Knowledge of GLP, GCP, data integrity, and regulatory requirements for foreign-generated study data.

• Experience working with international CROs and/or development programs involving studies conducted outside the United States.

• Ability to advise on FDA interactions, regulatory submissions, and overall development sequencing.

• Experience with feline therapeutics or clinical studies involving cats is highly desirable.

• Former FDA/CVM experience is a plus but not required.

Engagement Expectations

This is a strategic, remote consulting engagement supporting an early-stage veterinary biologics development program.

The selected consultant will work closely with the development team to establish a practical regulatory roadmap, refine the existing development plan, identify critical gaps, and ensure planned domestic and international development activities are positioned to support future FDA submissions.

Immediate availability is preferred, with the engagement targeted for completion by the end of 2026.