Rare Neurology Regulatory Strategy & Operations Consultant

Work Arrangement: Remote
Schedule: Initial 10–20 hours to assess current regulatory needs, with potential to expand to more substantial part-time or full-time support

Position Overview

We are seeking an experienced Regulatory Affairs Consultant to support a clinical-stage biotechnology organization advancing a therapeutic program for amyotrophic lateral sclerosis (ALS).

The consultant will provide strategic and hands-on regulatory support across clinical development, with particular emphasis on U.S. FDA strategy, IND maintenance, safety reporting, regulatory designations and expedited pathways, and the use of foreign clinical data to support U.S. development.

This engagement requires a consultant who can operate effectively within a lean biotechnology environment, providing senior-level regulatory guidance while also supporting day-to-day regulatory activities as needed. The consultant may also help strengthen internal regulatory capabilities through practical guidance, knowledge transfer, and recommendations for building a sustainable regulatory function.

Key Responsibilities

• Provide strategic regulatory guidance for an active clinical-stage ALS development program.

• Advise on U.S. FDA regulatory strategy and development planning from the current clinical stage through later-stage development and potential marketing application activities.

• Support ongoing IND maintenance and associated regulatory requirements.

• Provide guidance and hands-on support for clinical safety reporting and related regulatory activities.

• Assess strategies for leveraging foreign clinical data to support U.S. regulatory advancement.

• Advise on regulatory considerations associated with rare neurological disease development.

• Provide strategic guidance regarding Orphan Drug Designation (ODD), Breakthrough Therapy Designation, accelerated approval pathways, and other applicable regulatory mechanisms.

• Review development plans and identify regulatory risks, gaps, and opportunities that could affect program advancement.

• Support preparation for and strategy surrounding FDA interactions and regulatory submissions.

• Collaborate with clinical, nonclinical, clinical pharmacology, medical writing, and other development stakeholders.

• Provide flexible regulatory support ranging from focused strategic advisory work to more integrated, embedded support based on program needs.

• Help establish effective regulatory processes and internal capabilities appropriate for a lean clinical-stage biotechnology organization.

• Transfer regulatory knowledge to internal team members to strengthen long-term regulatory capabilities.

Required Qualifications

• Significant Regulatory Affairs experience supporting clinical-stage biotechnology or pharmaceutical development.

• Demonstrated experience with U.S. FDA regulatory strategy and IND-stage development.

• Experience supporting rare neurological disease development.

• Working knowledge of IND filings, maintenance, and ongoing regulatory requirements.

• Experience with regulatory strategy for clinical development programs, including FDA interactions and submissions.

• Knowledge of Orphan Drug Designation, Breakthrough Therapy Designation, accelerated approval pathways, and related regulatory considerations.

• Ability to provide both strategic regulatory guidance and hands-on operational support within a lean development organization.

• Strong cross-functional collaboration skills and ability to work effectively with scientific and clinical development teams.

Preferred Qualifications

• Experience supporting ALS therapeutic development.

• Experience with oligonucleotide and/or small molecule development programs.

• Experience evaluating or leveraging foreign clinical data for U.S. regulatory purposes.

• Hands-on experience with IND safety reporting and related regulatory operations.

Work Arrangement

This is a remote consulting engagement designed to provide flexibility as program needs evolve. The initial scope is expected to include approximately 10–20 hours focused on assessing current regulatory needs and priorities. Based on that assessment, the engagement may expand into more substantial part-time or full-time regulatory support, including more integrated participation with the development team while the organization strengthens its internal regulatory capabilities.

Ideal Candidate

The ideal consultant is a seasoned biotechnology Regulatory Affairs professional with direct experience in rare neurological disease development and strong knowledge of FDA IND requirements and expedited or special regulatory pathways. Experience with ALS and oligonucleotide or small molecule programs is particularly valuable. The consultant should be equally comfortable advising development leaders on regulatory strategy and working hands-on with the team to address operational regulatory needs.