Senior Director Regulatory Affairs, Advertising & Promotion
About The Position
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. 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.
Requirements
- 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
Nice To Haves
- Advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, Regulatory Affairs
- RA Certification (RAC)
- Knowledge of global promotional regulations would be a plus
Responsibilities
- 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
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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
