Former FDA Preclinical Regulatory Strategy Consultant

Work Arrangement: Remote
Start: As soon as possible

Position Overview

We are seeking a former FDA consultant to provide preclinical regulatory strategy support for a biotechnology organization developing a new formulation of an FDA-approved biologic. The program has completed multiple nonclinical studies, and the existing regulatory package has been discussed with FDA and is currently under agency review.

The immediate objective is to evaluate a proposed animal pharmacokinetic (PK) bridging strategy intended to support a potential waiver of additional human clinical studies. FDA feedback has emphasized aligning the proposed study design as closely as possible with the intended clinical indication.

The consultant will provide strategic guidance at the intersection of preclinical and clinical development, critically assess the proposed animal bridging approach, and advise on study design and regulatory positioning before the organization engages potential laboratories to conduct the study.

Key Responsibilities

• Review the existing regulatory strategy, relevant FDA feedback, and available nonclinical development package.
• Assess the scientific and regulatory viability of using an animal PK bridging study to support a potential waiver of additional human clinical studies.
• Evaluate the proposed use of an appropriate porcine wound or thermal injury model for the bridging study.
• Advise on whether the proposed animal data may be sufficient to support the intended regulatory strategy or whether additional clinical data may be expected.
• Recommend approaches for aligning the animal study design as closely as practical with the intended clinical indication and FDA feedback.
• Advise on key study design considerations that could influence FDA acceptance of the resulting data.
• Evaluate the interface between preclinical and clinical regulatory strategy and identify potential gaps or risks in the proposed development approach.
• Provide strategic input on regulatory pathway and positioning for subsequent FDA interactions.
• Help refine study requirements before they are presented to prospective laboratories.
• Advise on regulatory considerations associated with conducting the PK study in the United States or Europe, as appropriate.
• Participate in discussions with regulatory and clinical teams regarding study strategy and FDA expectations.
• Provide additional strategic regulatory guidance related to the development program as needs are identified.

Required Qualifications

• Former FDA experience relevant to preclinical/nonclinical development and regulatory strategy.
• Significant experience advising on preclinical regulatory strategy for biologic or pharmaceutical development programs.
• Strong understanding of FDA expectations for nonclinical study design and the use of animal data to support clinical and regulatory decision-making.
• Experience evaluating PK bridging strategies and the relationship between nonclinical and clinical development requirements.
• Ability to interpret FDA feedback and translate agency expectations into practical study-design recommendations.
• Experience advising development teams on regulatory strategy before initiation of pivotal or regulatory-supporting studies.
• Ability to work effectively across regulatory, preclinical, and clinical functions.

Preferred Qualifications

• Experience with wound, burn, or related therapeutic development programs.
• Experience with porcine models used in regulatory-supporting nonclinical studies.
• Familiarity with GLP studies conducted through external laboratories or contract research organizations.
• Experience advising on programs involving studies conducted in both the United States and Europe.

Ideal Candidate

The ideal consultant is a former FDA regulatory professional with deep expertise at the preclinical-clinical interface who can critically evaluate an animal bridging strategy from the agency perspective. This individual will be able to identify potential regulatory risks, strengthen the proposed PK study design, and provide practical guidance to improve the likelihood that the resulting data will address FDA expectations.