(StealthCo) Consultant: Regulatory Affairs

About the role:

A stealth mode biotech company is looking for an experienced, part time (20 hours/week) Regulatory Affairs Consultant to advise on the global regulatory strategy for its novel therapeutics. The consultant will give strategic and hands-on regulatory input as the company advances its programs through IND-enabling activities and into the clinic. This person will work closely with company leadership, internal teams, and the company's clinical development consultant to make sure clinical and regulatory strategies are aligned. They will also help plan and lead interactions with the FDA and other regulatory agencies. This is a chance to shape the regulatory path of new drugs for patients at an early-stage therapeutics company backed by highly regarded investors.

Key Responsibilities:

• Advise on regulatory strategy, program priorities, and regulatory pathways across the company's development portfolio
• Work closely with the clinical development consultant and internal teams to align regulatory strategy with clinical development plans, trial design, and program timelines
• Lead planning and preparation of IND submissions, including authoring, review, and coordination of nonclinical, clinical, and CMC (Module 3) sections
• Plan and prepare for interactions with regulatory