Verified Job
Advertising - Public Relations
Senior Director Regulatory Affairs, Advertising & Promotion
Advertising - Public Relations
#30508
Remote / WFH
Immatics US
Job Description
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
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
