NDA Regulatory Strategy Consultant (Remote)

NDA Regulatory Strategy Consultant

Location: Fully Remote
Work Arrangement: Remote
Start: Late Q4 2026 / Early Q1 2027
Schedule: Approximately 20 hours per week

Position Overview

We are seeking an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of New Drug Application (NDA) preparation for a life sciences organization.

The consultant will serve as a key regulatory advisor, providing overall strategic oversight of the NDA dossier and helping ensure the submission is complete, consistent, and positioned for FDA readiness. This individual will work closely with the existing regulatory project manager, regulatory writers, and internal stakeholders to review submission content, identify gaps and compliance risks, and maintain consistent regulatory messaging across the dossier.

This is a strategic but hands-on role requiring substantial direct NDA submission experience and the ability to operate independently with minimal guidance. The consultant may also serve as an interim senior regulatory lead while the organization recruits a permanent employee.

Key Responsibilities

• Provide senior-level strategic oversight of the NDA dossier during final preparation.
• Guide overall regulatory strategy and help ensure consistent messaging across the submission.
• Review NDA content for completeness, consistency, compliance risks, and FDA readiness.
• Identify regulatory gaps and recommend appropriate actions to address issues prior to submission.
• Work closely with the regulatory project manager, writers, and internal team to maintain alignment across submission activities.
• Provide practical regulatory guidance and decision support throughout the final stages of NDA preparation.
• Apply hands-on NDA submission experience to anticipate potential FDA concerns and strengthen submission readiness.
• Operate independently as a senior regulatory advisor with minimal oversight.
• Potentially serve as an interim senior regulatory lead until a permanent regulatory employee is hired.

Required Qualifications

• Significant hands-on experience preparing and supporting NDA submissions.
• Strong knowledge of FDA regulatory expectations applicable to NDA preparation and submission.
• Demonstrated ability to provide strategic oversight of complex regulatory dossiers.
• Experience reviewing submission content, identifying regulatory gaps and compliance risks, and supporting FDA readiness.
• Ability to collaborate effectively with regulatory project management, writing, and cross-functional internal teams.
• Ability to operate independently and provide senior-level regulatory guidance with minimal direction.

Ideal Candidate

The ideal consultant is a seasoned regulatory professional with substantial hands-on NDA submission experience who can quickly step into a senior advisory role. This individual will combine strategic regulatory judgment with detailed dossier review capabilities and be comfortable serving as a trusted regulatory lead during a critical stage of submission preparation.