Senior Director, Regulatory Affairs – Advertising & Promotion

Vaga não está no LinkedIn

🕒 Junho 5

🤠 Texas – Remoto

🤠 Texas – Remote

💵 $279.000 - $300.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Immatics

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2000

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

Biotechnology • Pharmaceuticals • Science

A Immatics é uma empresa de biotecnologia focada no desenvolvimento de imunoterapias direcionadas para pacientes com câncer, especialmente no tratamento de tumores sólidos. A empresa combina a descoberta de alvos de imunoterapia contra o câncer com o desenvolvimento de receptores de células T específicas para possibilitar uma resposta imunológica robusta. O pipeline da Immatics inclui Terapias de Células Adotivas e TCR Bispecíficos, e colabora com líderes globais na indústria farmacêutica. A missão da empresa é avançar suas terapias para melhorar a vida dos pacientes com câncer, mantendo um forte compromisso com a inovação em tecnologias de imunoterapia.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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