Senior Director, Regulatory Affairs – Advertising & Promotion

Emploi pas sur LinkedIn

🕒 il y a 20 jours

🤠 Texas – Distant

🤠 Texas – Remote

💵 $279 000 - $300 000 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Immatics

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2000

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

Biotechnology • Pharmaceuticals • Science

Immatics est une société de biotechnologie spécialisée dans le développement d'immunothérapies ciblées pour les patients atteints de cancer, notamment dans le traitement des tumeurs solides. La société combine la découverte de cibles d'immunothérapie contre le cancer avec le développement de récepteurs de cellules T spécifiques pour permettre une réponse immunitaire robuste. Le pipeline d'Immatics comprend des thérapies cellulaires adoptives et des bispécifiques de récepteurs de cellules T (TCR), et elle collabore avec des leaders mondiaux de l'industrie pharmaceutique. La mission de l'entreprise est de faire progresser ses thérapies pour améliorer la vie des patients atteints de cancer et elle maintient un fort engagement envers l'innovation en technologies d'immunothérapie.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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