Regulatory Affairs Consultant

The consultant may support some or all of the following, based on experience and the company's priorities: Regulatory strategy input for programs moving from Phase II toward Phase III and registration Preparation of FDA and EMA meeting packages, including briefing documents for End of Phase II, Type B and Type C meetings Authoring and review of IND amendments, annual reports, expedited pathway requests and other submissions BLA readiness activities, such as gap analyses, submission planning and Module 2 content review Health authority question responses and correspondence Regulatory intelligence and precedent research for oncology and autoimmune biologics Ad hoc strategic advice to the regulatory leader and program teams Required Qualifications 10+ years of regulatory affairs experience in biotech, pharma or a regulatory consultancy Experience supporting clinical stage programs, with exposure to late stage development and FDA meetings Strong regulatory writing skills, including briefing documents and submission content Experience with biologics or large molecule therapeutics Comfort working independently and flexibly within a lean biotech team Availability for a consistent part time commitment

Preferred Qualifications

Phase III, BLA or launch experience Oncology, hematology or autoimmune therapeutic area experience Experience with antibodies, bispecifics or cell depleting therapies EMA and global regulatory experience Prior FDA experience or a background in a regulatory consultancy