[Remote] Sr. Regulatory Affairs Lead

Note: The job is a remote job and is open to candidates in USA. Peritia is a consulting firm serving the biopharmaceutical industry in clinical development, value, and evidence. The Senior Regulatory Affairs Consultant will serve as the regulatory lead for an early-stage biotech developing a CAR-T immunotherapy, owning FDA strategy and execution through IND clearance. The role will assess existing data, lead FDA interactions, pursue RMAT designation, and author and oversee IND compilation.

Responsibilities
• Assess existing CMC, nonclinical, and clinical data, including IIT data and reports prepared in Chinese, for completeness and compliance with FDA requirements, and recommend a plan to close gaps
• Develop a plan to ensure the IIT data can support the upcoming filing
• Develop the overall FDA regulatory strategy, including the path to initiate a Phase 2 study with a non-traditional design
• Advise on the regulatory implications of the manufacturing site decision (Prague vs. China), including product comparability between the IIT manufacturing processes and the processes intended for the US study
• Plan and lead FDA interactions (INTERACT and/or pre-IND meetings), including meeting requests and briefing documents
• Prepare and submit a Regenerative Medicine Advanced Therapy (RMAT) designation request
• Author and oversee compilation of the IND

Skills
• 7+ years in regulatory affairs, including roles with decision-making and strategic leadership responsibility
• Direct experience interacting with CBER's Office of Therapeutic Products (OTP) on oncology cell therapy programs, including coordination with the Oncology Center of Excellence (OCE)
• A track record of independently developing regulatory strategy for T-cell therapies (CAR-T, TCR-T)
• Hands-on authorship of FDA meeting requests, briefing documents, and expedited program designation requests (RMAT, Fast Track, or Breakthrough Therapy)
• Experience writing and leading the assembly of an IND for cell therapy
• Experience with solid tumor oncology programs
• Ability to write with precision, producing clear, persuasive regulatory documents that hold up to FDA scrutiny
• Experience using foreign or investigator-sponsored clinical data to support a US development program preferred
• Experience working with manufacturing or clinical partners in China strongly preferred
• Thrives in a startup style environment with a highly collaborative mindset and a desire to positively impact a new company's culture (small biotech mentality)
• Passionate, adaptable, and keen on working in the fast-paced biotech startup space to drive cutting-edge science

Benefits
• Remote work arrangement
• Multi-year consulting commitment of at least 10 hours per week
• Highly collaborative startup environment
• Opportunity to positively impact a new company’s culture
• Work in the fast-paced biotech startup space
• Drive cutting-edge science

Company Overview
• Hiring Solutions It was founded in undefined, and is headquartered in , with a workforce of 0-1 employees. Its website is .