Associate Manager, Regulatory Advertising & Promotion

🕒 Outubro 24

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $109.900 - $179.300 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

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Regeneron

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1988

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

💰 Post-IPO Equity em 2023-10

Healthcare • Manufacturing • Biotechnology

A Regeneron é uma empresa de biotecnologia dedicada a transformar descobertas científicas em medicamentos que mudam vidas. A empresa se concentra em uma variedade de doenças graves, incluindo doenças alérgicas, cardiovasculares e metabólicas, neurociência, oncologia, hematologia, oftalmologia e doenças raras. Isso é alcançado integrando biologia e tecnologia para desenvolver biológicos inovadores e medicamentos genéticos. A Regeneron está comprometida com a equidade em saúde, sustentabilidade ambiental e apoio ao talento futuro em STEM por meio de iniciativas como o Regeneron Science Talent Search. Mantendo altos padrões éticos e responsabilidade corporativa, a Regeneron visa ultrapassar os limites da ciência para melhores soluções de saúde.

Descrição

• Contribute to management of US regulatory activities associated with advertising and promotion of marketed products • Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director • Advise on development of product messages and materials across multiple functional areas • Provide regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibits, disease awareness, and speaker programs • Review US and Global product and disease-state materials and communications • Collaborate with Marketing, Medical Affairs, Legal, and other key stakeholders • Manage communication with regulatory advertising and promotion professionals at co-promote partner companies • Assist with interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions • Maintain compliance with promotional material submissions to the FDA on Form 2253 • Monitor evolving regulatory requirements for product and disease-state communications • Monitor FDA promotional enforcement activities and assess impacts on company policies • Support process improvement and portfolio-wide standardization of promotional review policies • Provide continuous Regulatory Advertising and Promotion support to stakeholders • Collaborate with Regulatory Therapeutic Area Leads to review marketing application summaries and study reports • Support commercialization objectives and messaging in regulatory submission documents and reports • Work with management during labeling development and negotiation to reflect commercialization objectives affecting promotion and advertising

🎯 Requisitos

• A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion, or completion of a Post-Doctoral Fellowship Program with related Regulatory Affairs experience • Minimum requirement is a Bachelor's degree (BS) from an accredited college or university in Life Sciences • Advanced scientific degree (Masters, PharmD, or Ph.D.) strongly preferred • Fundamental understanding of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focused on advertising and promotion • Experience with pharmaceutical products highly preferred; biologics experience is a plus • Experience working directly or indirectly with the FDA, specifically OPDP/APLB, is desirable • Ability to review promotional materials and interact with FDA OPDP/APLB • Ability to support launch products and campaigns • Excellent written and verbal communication skills • Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable • Ability to influence and guide cross-functional teams • Ability to interact effectively with senior management and colleagues at all levels

🏖️ Benefícios

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process where required

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