Senior Director, Regulatory Affairs – Advertising & Promotion

Immatics

Senior Director of Regulatory Affairs at Immatics leading promotional material compliance for cancer immunotherapy. Overseeing FDA compliance and regulatory strategies in a fully remote role.

Posted 6/5/2026full-timeRemote • Texas • 🇺🇸 United StatesSenior💰 $279,000 - $300,000 per yearWebsite

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Hard Skills

FDA compliancepromotional compliancelabel negotiationsadvertising copy reviewpromotional claims managementdigital media compliancescientific exchangemisbranding remediationbudget managementresource allocation

Soft Skills

leadershipmentoringoperational deliverycommunicationcollaboration

Tools & Technologies

Form FDA 2253

Certifications & Qualifications

RA Certification (RAC)

Industry Keywords

Regulatory AffairspharmabiotechFDCAFDAMAOPDPCOPPhRMA Codefair balanceadvertising/promotion

About the role

Key responsibilities & impact

Serving as the primary U.S Regulatory expert for promotional materials through Immatics’ pipeline and any future commercial launches
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
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
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
Mentor junior RA professionals; oversee operational delivery and resource allocation
Manage budget for Ad/Promo activities and ensure cohesive execution across programs

Requirements

What you’ll need

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
Advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, Regulatory Affairs (preferred)
RA Certification (RAC)
Knowledge of global promotional regulations would be a plus

Benefits

Comp & perks

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
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