Contract Regulatory Affairs Consultant – Pre-IND Strategy 

Our client is a clinical-stage biotechnology company is seeking an experienced Regulatory Affairs consultant to support preparations for an upcoming Pre-IND meeting and regulatory engagement with health authorities in Australia. This is a 1099 consulting engagement ideal for a senior regulatory leader who has experience guiding early development programs and preparing companies for initial regulatory interactions.

The consultant will provide strategic guidance on Pre-IND preparation, including developing key briefing materials, advising on regulatory strategy, and supporting communications with Australian health authorities. This individual will work closely with internal clinical, regulatory, and scientific teams to ensure the program is well positioned for productive regulatory dialogue and alignment on development plans.

The ideal consultant will bring strong experience in early-stage regulatory strategy, including direct involvement in Pre-IND or similar regulatory meetings, along with a background in autoimmune or immunology programs. Experience supporting international regulatory interactions and familiarity with the Australian regulatory landscape is preferred. Having established regulatory writing templates or frameworks to accelerate preparation of briefing materials will be highly beneficial.

This is expected to be a 12-month consulting engagement, starting at approximately up to 20 hours per week, with increased involvement anticipated as the organization approaches key regulatory meetings.