Senior NDA Regulatory Strategist — Remote, Part-Time

The FDA Group; Boston (MA); Remote; USD 165,000 - 262,000; Part time

Benefits offered by this job

Fully remote

Job summary

The FDA Group seeks an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of NDA preparation for a life sciences organization. This remote, part-time role focuses on ensuring the submission is complete, consistent, and positioned for FDA readiness.

The consultant will align with the regulatory project manager, writers and internal stakeholders, review content for gaps and compliance risks, and offer practical guidance.

Qualifications

• Significant hands-on experience preparing and supporting NDA submissions.
• Strong knowledge of FDA regulatory expectations for NDA processes.
• Ability to provide strategic oversight of complex regulatory dossiers.
• Experience reviewing NDA content for gaps and compliance risks.
• Ability to work independently with minimal direction and lead cross-functional teams.

Responsibilities

• Provide senior-level strategic oversight of the NDA dossier.
• Guide regulatory strategy and ensure consistent messaging.
• Review NDA content for completeness and FDA readiness.
• Identify regulatory gaps and recommend actions.
• Collaborate with regulatory PM, writers, and internal teams.
• Provide practical regulatory guidance throughout final NDA prep.
• Apply NDA submission experience to anticipate FDA concerns.
• Serve as interim senior regulatory lead if needed.

Skills

NDA submissions

Regulatory strategy

FDA readiness

Cross-functional collaboration

Independent work

Job description

The FDA Group seeks an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of NDA preparation for a life sciences organization. This remote, part-time role focuses on ensuring the submission is complete, consistent, and positioned for FDA readiness.

The consultant will align with the regulatory project manager, writers and internal stakeholders, review content for gaps and compliance risks, and offer practical guidance.