Senior Regulatory Affairs Consultant, IND Strategy & Development

Xythena is supporting a biotech client in the search for a Senior Regulatory Affairs Consultant to help lead IND strategy, development, and submission activities for a growing and innovative organization. This role is ideal for someone who combines deep regulatory judgment with genuine curiosity about how better systems, smarter workflows, and emerging technologies can improve the way INDs are developed. You should be the kind of person who is energized by solving hard problems, enjoys working across disciplines, and sees regulatory writing not just as a documentation exercise, but as a strategic function that can evolve meaningfully. The right candidate brings strong experience across IND applications, with particular depth in nonclinical content, and enough breadth in CMC and clinical sections to contribute across the full dossier. Just as important, this person should be comfortable engaging with technical teams and helping shape more efficient, forward-looking ways of working. What you’ll do

• Lead and support the planning, development, review, and submission of IND applications.
• Provide strategic regulatory input for programs moving toward first-in-human studies, with particular emphasis on nonclinical sections.
• Translate complex scientific data into clear, persuasive, submission-ready regulatory content.
• Partner closely with cross-functional teams across nonclinical, CMC, clinical, regulatory, and technical operations.
• Identify content gaps, submission risks, and opportunities to improve quality and efficiency early in the process.
• Contribute to a more integrated and scalable approach to regulatory document development.
• Help bridge domain expertise and technical implementation by working effectively with internal technology and operations teams.
• Bring thoughtful input on document workflows, structured content, review processes, and new approaches to regulatory authoring.

What we’re looking for

• Significant experience in regulatory affairs in biotech, pharma, or a consulting environment.
• Strong track record supporting or leading IND submissions.
• Deep expertise in nonclinical IND content, including strong familiarity with toxicology, pharmacology, and related regulatory expectations.
• Practical experience with CMC and clinical content sufficient to work across the broader IND package.
• Excellent scientific writing and editing skills, with strong attention to clarity, logic, and submission readiness.
• Ability to operate at both strategic and hands-on levels.
• Comfort working in an evolving, cross-functional environment where scientific, operational, and technical thinking intersect.
• Strong communication skills and the ability to engage productively with technical teams on workflow, tooling, and process design.
• A mindset that is adaptable, curious, and energized by the opportunity to improve how regulatory work gets done.

Why this role stands out This is not a traditional regulatory consulting role built around maintaining the status quo. It is an opportunity to apply deep IND expertise in an environment that values rigor, clear thinking, collaboration, and better ways of working. This role will be especially compelling to someone who:

• enjoys building, not just maintaining
• is excited by thoughtful innovation in regulatory practice
• sees technology as a way to extend expert judgment, not replace it
• wants to help shape how high-quality INDs are developed in the next generation of biotech companies

If you are a strong regulatory leader who takes pride in scientific quality, values intellectual openness, and is excited by where the field is going, we would love to hear from you. Pay: $120,000.00 - $150,000.00 per year Benefits:

• 401(k)
• Health insurance

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