Immatics
Healthcare
SeniorDirectorRegulatoryAffairs,Advertising&Promotion
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“Senior Director Regulatory Affairs, Advertising & Promotion at Immatics. Skills: Advertising & Promotion, Regulatory affairs, Promotional compliance. Serve as U.S. Regulatory expert. Chair and lead PRC”
Industry & Context.
Occasional domestic travel, Occasional international travel
What They're Looking For.
Must Have
Bachelors in Life Sciences, 12+ years Regulatory Affairs, FDA-regulated promotional compliance, FDCA, OPDP, FDAMA, PDMA, PhRMA Code knowledge
Nice to Have
Advanced degree, RA Certification (RAC), Global promotional regulations knowledge
What You'll Do.
Serve as U.S. Regulatory expert
Align with Prescribing Information
Ensure compliance with rules
Ensure strategy consistency with FDCA
Prepare and file pre-clearance materials
Lead OPDP interactions
Respond to enforcement letters
Support label negotiations
Review advertising copy
Review promotional claims
Review speaker programs
Review digital/social media materials
Review HCP-facing promotions
Identify and remediate claims
Manage recall activities
Manage mitigation activities
Oversee operational delivery
Oversee resource allocation
Manage budget for Ad/Promo activities
Ensure cohesive execution
How You'll Work.
Team & Collaboration
Cross-functional teams
Communication Scope
Executive presentations
Full 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 Prescribi
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