Senior Director Regulatory Affairs, Advertising & Promotion

Join Immatics and shape the future of cancer immunotherapy ; one patient at a time!

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME , a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Why Join Us?

Innovative Environment: Help pioneer advancements in cancer immunotherapy

Collaborative Culture: Be part of a diverse team dedicated to your professional growth

Global Impact: Contribute to therapies that make a lasting impact on patients globally

Role Overview

We are seeking a Senior Director, Regulatory Affairs Advertising & Promotionto support our Regulatory Affairs team. The Senior Director will be responsible for Serving as the primary U.S Regulatory expert for promotional materials through Immatics ’ pipeline and any future commercial launches.

Schedule : 8:00 AM – 5:00 PM; Monday to Friday Reports to : Global Head of Regulatory Affairs Location : Fully Remote

Salary Range: $279,000 - $300,000

Basic Qualifications:

Bachelors in Life Sciences, Pharmacy, Regulatory Affairs

12+ years in pharma/biotech Regulatory Affairs with Advertising/Promotion focus including leadership responsibility

Proven expertise in FDA-regulated promotional compliance, COP/OPDP, and PI/label negotiations

Comprehensive knowledge of FDCA, OPDP, FDAMA, PDMA, PhRMA Code, scientific exchange, misbranding, and fair balance

Preferred Qualifications:

Advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, Regulatory Affairs

RA Certification (RAC)

Knowledge of global promotional regulations would be a plus

In this role you will:

Strategic Regulatory Leadership

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

Labelling & FDA Liaison

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

Promotional Compliance Oversight

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

Team Leadership & Budget Management

Mentor junior RA professionals; oversee