Senior Director Regulatory Affairs, Advertising & Promotion

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
• 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
• 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

Benefits

Additional Information

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

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