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 & Promotion to 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 operational delivery and resource allocation Manage budget for Ad/Promo activities and ensure cohesive execution across programs Travel required: Occasional domestic or international travel Qualified candidates will participate in a structured interview process, which includes: An initial recruiter phone screen (conducted via video) A recruiter-facilitated introduction and interview with the hiring leader and key stakeholders (via video) A final-stage interview, which may include an in-person meeting at our U.S. Headquarters in Houston, TX What do we offer? At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics: Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance 4 weeks of vacation granted up front each year and prorated for first and last year of employment 12 company paid holidays 7 days of sick time 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars 100% employer-paid short- and long-Term disability coverage 401(k) with immediate eligibility and company match The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment Partially paid parental leave for eligible employees Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance Equal Employment Opportunity We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law. Reasonable Accommodations We are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us at [email protected]. Work Authorization Applicants must be authorized to work in the United States without the need for current or future sponsorship. Visa sponsorships may be available for certain roles. Pre-Employment Requirements Employment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening, where permitted by applicable law. For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job-related and consistent with business necessity. Apply To This Job