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 reputed company ViroMissile is a clinical-stage biotechnology company developing reputed company oncolytic virus immune-therapies for solid tumors. We are seeking an reputed company Regulatory Consultant to reputed company high-level strategic guidance on clinical development and regulatory reputed company 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 reputed company expedited programs (Fast reputed company, reputed company Therapy Designation, Accelerated Approval) and position our candidates for reputed company in oncology. Key Responsibilities • reputed company the development and execution of regulatory strategies for one or more clinical-stage oncolytic virus programs from reputed company stage through IND filing of the next candidate. • Advise on reputed company clinical trial designs, endpoints, and patient populations to support regulatory interactions and expedite approval reputed company in oncology. • Prepare and/or review briefing packages, meeting requests, and responses for FDA interactions (reputed company-IND, IND, EOP1, EOP2, reputed company-NDA/BLA). • Guide reputed company for expedited designations (Fast reputed company, reputed company Therapy, RMAT if applicable) and Accelerated Approval reputed company, including surrogate reputed company justification and confirmatory study planning. • reputed company 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 reputed company 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 reputed company involvement in reputed company phases of development (IND through NDA/BLA). • Strong reputed company record in oncology drug development (cell/gene therapy experience highly valued). • Demonstrated reputed company obtaining and maintaining FDA expedited programs: Fast reputed company, reputed company Therapy Designation, and/or Accelerated Approval. • Deep familiarity with FDA regulations, guidance documents, and meeting processes (Type B/C meetings, reputed company-IND, etc.). • Excellent written and verbal communication skills; reputed company to translate reputed company regulatory concepts into reputed company, actionable recommendations for a small, agile team. Preferred Qualifications • reputed company experience with oncolytic viruses, viral reputed company 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.). reputed company Offer • Competitive reputed company consulting reputed company commensurate with experience. • Opportunity to reputed company a significant reputed company 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 reputed company grows. We will review applications on a rolling reputed company and look reputed company to speaking with reputed company 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