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 RecruitingUS@immatics.com.   
 
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.