Immatics

Compliance

• Serving as the primary U.S Regulatory expert for promotional materials through Immatics’ pipeline and any future commercial launches
• Chair and lead PRC, ensuring “fair balance,” alignment with Prescribing Information (PI), and compliance with scientific exchange and misbranding rules
• Ensure U.S advertising and promotional strategy consistency with FDCA, FDAMA, FD&C labelling, and OPDP guidance
• Prepare and file pre-clearance materials via Form FDA 2253, lead OPDP interactions, and respond to enforcement letters/advisories
• Support label negotiations for PI, carton/container, and PPI
• Review advertising copy, promotional claims, speaker programs, digital/social media materials, and HCP-facing promotions for FDA compliance
• Identify and remediate claims, manage recall and mitigation activities when necessary
• Mentor junior RA professionals; oversee operational delivery and resource allocation
• Manage budget for Ad/Promo activities and ensure cohesive execution across programs

Senior Director, Regulatory Affairs – Advertising & Promotion

Research Analyst

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Senior Clinical Research Associate

Manager

• Support the execution of our clinical trials, including the SUPRAME (IMA203-301) study.
• Responsible for supporting patient journey navigation, primarily for U.S. sites.
• Update patient-facing and clinical trial materials.
• Contribute to protocol development.
• Conduct literature research.
• Support trial outcome reporting.
• Deliver training to internal and external stakeholders.
• Serve as a key point of contact for clinical trial protocol and patient-facing material inquiries from sites and internal teams.
• Support patient journey navigation, including proactive management of screening activities.
• Contribute to authoring and updating clinical trial documents, including protocols, reports, and investigator materials.
• Support preparation of responses for IRBs and regulatory authorities.
• Deliver site training on clinical trial protocols and patient-facing materials (e.g., SIVs).
• Maintain accurate eTMF documentation and filing.
• Travel required: up to 20% travel required , domestically and internationally.

Senior Director, Regulatory Affairs – Advertising & Promotion

Senior Clinical Research Associate

Senior Clinical Sciences Manager