Senior FDA Regulatory Strategy Consultant – Drug-Device Combination Products

Location: United States (U.S.-based consultant preferred)
Work Arrangement: Remote / Advisory Consulting
Start: Late 2026 / Early 2027
Schedule: Part-time, variable hours based on project needs

Position Overview

We are seeking a Senior FDA Regulatory Strategy Consultant with significant drug-device combination product experience to support a biotechnology organization advancing a therapeutic development program toward FDA submission and regulatory engagement.

The organization has an established regulatory strategy and works with an existing international regulatory consulting team. An additional senior U.S. regulatory advisor is needed to provide independent strategic guidance, critically assess FDA expectations, and strengthen preparation for upcoming regulatory interactions.

This is primarily a strategic advisory engagement rather than a hands-on submission-authoring or regulatory execution role. The consultant will serve as a trusted regulatory sounding board, helping the development team evaluate proposed approaches, identify regulatory risks, and determine practical paths forward.

Former FDA experience is required, particularly in a regulatory review, leadership, or decision-making capacity involving drug-device combination products.

Key Responsibilities

• Provide senior-level FDA regulatory strategy guidance for a drug-device combination product approaching regulatory submission and agency interactions.

• Review and critically assess the existing U.S. regulatory strategy, identifying gaps, potential regulatory risks, and opportunities for improvement.

• Advise on FDA expectations for combination products incorporating drug-eluting or locally administered therapeutic delivery technologies.

• Evaluate regulatory considerations involving previously approved drug components, investigational active ingredients, and established drug-delivery materials.

• Provide strategic input regarding product classification, regulatory pathways, and regulatory implications of integrating pharmaceutical and device components.

• Support preparation for FDA meetings, including review of proposed questions, briefing materials, and regulatory positions.

• Participate in FDA meetings and provide direct regulatory representation or subject-matter expertise as appropriate.

• Interpret FDA feedback and translate agency expectations into clear, actionable recommendations.

• Evaluate proposed development and submission strategies, communicating regulatory limitations, risks, and viable alternatives.

• Collaborate directly with internal leadership and existing international regulatory consultants.

• Provide responsive, ongoing advisory support as the development program progresses through regulatory milestones.

Required Qualifications

• Former FDA experience in a regulatory review, leadership, or decision-making capacity involving drug-device combination products.

• Significant experience developing and evaluating U.S. FDA regulatory strategies.

• Demonstrated regulatory expertise with drug-device combination products and applicable FDA regulatory pathways.

• Strong understanding of FDA expectations for products integrating pharmaceutical and medical device components.

• Experience supporting regulatory submission planning, FDA meeting preparation, and agency interactions.

• Ability to critically evaluate regulatory approaches and provide practical recommendations regarding feasibility and potential FDA acceptance.

• Strong communication skills, including the ability to explain complex regulatory considerations to scientific, technical, and executive stakeholders.

• Experience collaborating with multidisciplinary development teams and external regulatory advisors.

• Ability to provide independent, responsive, senior-level strategic guidance.

Preferred Qualifications

• Direct regulatory experience with drug-eluting, embolic, or locally administered therapeutic delivery technologies.

• Experience with combination products incorporating investigational pharmaceutical ingredients and established drug-delivery materials.

• Experience advising biotechnology or pharmaceutical organizations during development and pre-submission regulatory planning.

• Experience providing independent regulatory advisory support to early-stage life sciences organizations.

• U.S.-based consulting availability.

Work Arrangement

This is a remote, senior-level advisory consulting engagement with variable hours based on regulatory activities and project needs. The opportunity is well suited for an experienced consultant who can provide flexible strategic support alongside other consulting engagements.

The consultant will work directly with the development team and existing international regulatory advisors, participating in scheduled strategy discussions, regulatory reviews, FDA meeting preparation, and agency interactions as needed.

The level of support may fluctuate as the development program progresses through regulatory milestones.

Ideal Candidate

The ideal candidate is a seasoned FDA regulatory strategist with former FDA experience and substantial drug-device combination product expertise. Experience with drug-eluting or embolic technologies is particularly valuable.

This individual brings strong regulatory judgment, credibility, responsiveness, and the ability to provide clear, independent guidance. The successful consultant will be comfortable constructively challenging proposed regulatory approaches, collaborating with an established international team, and helping the organization navigate consequential FDA interactions.