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.