Position Overview

This key role will focus on the tactical and strategic oversight of early-phase and late-phase regulatory activities to ensure compliance and support innovative product development. The successful candidate will combine hands-on expertise in regulatory affairs with a proactive approach to solving complex challenges in clinical development.  

Responsibilities 

Regulatory Strategy Development  

• Contribute to the design and execution of global regulatory strategies for early-phase development programs.  
• Provide regulatory guidance to cross-functional teams, ensuring alignment with Immunome’s objectives and compliance with regulatory requirements.  
• Identify and assess potential regulatory risks and develop mitigation strategies.  

Tactical Implementation  

• Prepare, review, and submit regulatory documents for early and late-phase clinical programs (e.g., INDs, CTAs, amendments).  
• Coordinate and oversee the preparation of technical content, including CMC, non-clinical, and clinical sections of regulatory submissions.  
• Manage timelines and ensure regulatory milestones are met.  
• Serve as a subject matter expert on regulatory systems (e.g., Veeva Vault), overseeing system use in collaboration with IT and Quality, user training and data archiving.  
• Contribute to department infrastructure development by initiating processes targeted towards efficiency, quality, compliance and collaboration.  

Regulatory Interactions  

• Act as a primary contact for regulatory authorities (e.g., FDA, EMA) for early and/or late-phase development programs.  
• Plan and participate in meetings with regulatory agencies, preparing briefing packages, and coordinating follow-ups.  
• Monitor and interpret regulatory guidelines and communicate implications to internal stakeholders.  

Cross-Functional Collaboration  

• Work closely with research, development, CMC, and quality teams to ensure seamless regulatory support.  
• Provide regulatory input during protocol development, study design, and data interpretation.  
• Train and mentor team members on regulatory processes and requirements.  

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (PhD, PharmD, MS) preferred.  
• 7+ years of experience in regulatory affairs with a strong emphasis on early-phase drug development, or equivalent experience. Oncology, rare disease, or similarly complex experience is required.   
• Demonstrated experience in preparing and submitting regulatory filings (e.g., INDs, CTAs).  

Knowledge and Skills

• In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).  
• Proven ability to manage multiple projects and priorities in a fast-paced environment.  
• Strong interpersonal and communication skills, with experience engaging regulatory agencies.  
• Experience with immunotherapies or biologics is highly desirable.