Regulatory Affairs Consultant

X4 Life Sciences; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

X4 Life Sciences seeks a Regulatory Affairs Consultant with deep US FDA experience to lead feasibility studies, FDA dossier preparation, and GRAS/NDI submissions for a diverse client base. You will navigate complex regulations, advise on ingredient registrations, and ensure timely project delivery with senior-level regulatory judgment.

Fully remote, US-based role offering autonomy, collaboration, and opportunities to tackle challenging regulatory cases across ingredients, manufacturing

Qualifications

• 7-10+ years' relevant regulatory experience across FDA-led submissions.
• Strong background in GRAS and NDI regulatory pathways for ingredients.
• Experience preparing regulatory dossiers and communicating with clients.

Responsibilities

• Lead regulatory feasibility and classification assessments.
• Conduct gap assessments of manufacturing processes.
• Prepare and submit FDA regulatory dossiers.
• Support GRAS and NDI submissions.
• Assemble and work with GRAS expert panels.
• Advise clients across a wide variety of ingredients.
• Demonstrate senior-level regulatory judgement with a proven track record.
• Leverage ex-FDA experience to guide projects and timelines.

Skills

FDA regulatory experience

GRAS/NDI expertise

Regulatory strategy

Client-facing

Ex-FDA experience

Toxicology knowledge

Education

PhD in Toxicology/Regulatory Science

Job description

Regulatory Affairs Consultant | US FDA | GRAS & NDI

We’re working with an established Regulatory Consulting firm to find a Regulatory Affairs Consultant with strong US FDA regulatory experience.

Regulatory Consultant - Responsibilities & Experience

• Lead regulatory feasibility and classification assessments
• Conduct gap assessments of manufacturing processes
• Prepare and submit FDA regulatory dossiers
• Support GRAS and NDI submissions
• Assemble and work with GRAS expert panels
• Advise clients across a wide variety of ingredients
• 7-10+ years' relevant experience, or equivalent depth
• Strong toxicology background - PhD preferred
• Significant GRAS/NDI and FDA experience
• Ex-FDA experience highly desirable
• Broad ingredient experience and strong client-facing skills
• Senior-level regulatory judgement and a proven track record

The role is fully remote, and US-based position.

You’ll join a regulatory consulting team where people have genuine autonomy, collaborate closely and have the freedom to take on interesting and complex cases