Associate Director, Regulatory Affairs

Responsibilities

• Contribute to the design and execution of global regulatory strategies for early-phase development programs
• Provide regulatory guidance to cross-functional teams to ensure compliance
• Identify and assess potential regulatory risks and develop mitigation strategies
• Prepare, review, and submit regulatory documents such as INDs, CTAs, and amendments
• Coordinate the preparation of technical content including CMC, non-clinical, and clinical sections
• Serve as a subject matter expert on regulatory systems like Veeva Vault
• Act as a primary contact for regulatory authorities including the FDA and EMA
• Plan and participate in meetings with regulatory agencies and prepare briefing packages
• Work closely with research, development, CMC, and quality teams

Requirements

• Bachelor’s degree in life sciences, pharmacy, or related field
• 7+ years of experience in regulatory affairs with an emphasis on early-phase drug development
• Required experience in oncology, rare disease, or similarly complex therapeutic areas
• Demonstrated experience preparing and submitting regulatory filings (INDs, CTAs)
• In-depth knowledge of FDA, EMA, and ICH guidelines

Preferred Qualifications

• Advanced degree (PhD, PharmD, MS)
• Experience with immunotherapies or biologics

About the Company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, including antibody-drug conjugates.