Regulatory Consultant

Job Title Regulatory Consultant (Part-Time, Remote) Company ViroMissile, Inc. Location Fully remote (U.S. preferred) Commitment 5–10 hours per week, flexible scheduling, through IND filing of the next clinical candidate (anticipated 3–6 months) Position Overview ViroMissile is a clinical-stage biotechnology company developing next-generation oncolytic virus immune-therapies for solid tumors. We are seeking an experienced Regulatory Consultant to provide high-level strategic guidance on clinical development and regulatory pathways for our pipeline programs. You will serve as the primary regulatory strategist, working closely with our internal clinical, CMC, and translational teams to design efficient, approvable development plans that leverage expedited programs (Fast Track, Breakthrough Therapy Designation, Accelerated Approval) and position our candidates for success in oncology. Key Responsibilities • Lead the development and execution of regulatory strategies for one or more clinical-stage oncolytic virus programs from current stage through IND filing of the next candidate. • Advise on optimal clinical trial designs, endpoints, and patient populations to support regulatory interactions and expedite approval pathways in oncology. • Prepare and/or review briefing packages, meeting requests, and responses for FDA interactions (pre-IND, IND, EOP1, EOP2, pre-NDA/BLA). • Guide strategy for expedited designations (Fast Track, Breakthrough Therapy, RMAT if applicable) and Accelerated Approval pathways, including surrogate endpoint justification and confirmatory study planning. • Provide regulatory intelligence on evolving FDA/EMA guidance relevant to oncolytic viruses and advanced therapies. • Collaborate with the internal team to ensure alignment between clinical, manufacturing, and nonclinical plans and regulatory expectations. • Participate in ad-hoc meetings (typically 1–2 per week) and be available for targeted document review. Required Qualifications • Minimum 10 years of regulatory affairs experience in the biopharmaceutical industry, with direct involvement in all phases of development (IND through NDA/BLA). • Strong track record in oncology drug development (cell/gene therapy experience highly valued). • Demonstrated success obtaining and maintaining FDA expedited programs: Fast Track, Breakthrough Therapy Designation, and/or Accelerated Approval. • Deep familiarity with FDA regulations, guidance documents, and meeting processes (Type B/C meetings, pre-IND, etc.). • Excellent written and verbal communication skills; able to translate complex regulatory concepts into clear, actionable recommendations for a small, agile team. Preferred Qualifications • Direct experience with oncolytic viruses, viral vector therapies, or other live-virus products. • Prior consulting or fractional regulatory leadership experience in small biotech companies. • Experience with both U.S. and ex-U.S. regulatory interactions (EMA, Health Canada, etc.). What We Offer • Competitive hourly consulting rate commensurate with experience. • Opportunity to make a significant impact on the development of potentially transformative cancer therapies. • Fully remote, flexible engagement with a lean, science-driven team. • Possibility of extension or transition to broader scope as the company grows. We will review applications on a rolling basis and look forward to speaking with experienced regulatory leaders who are excited to help bring innovative oncolytic virus therapies to patients. ViroMissile, Inc., is an equal opportunity employer. Apply tot his job Apply To this Job