Senior Manager, Regulatory Affairs, Advertising & Promotion

🕒 Outubro 24

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $150.500 - $245.500 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 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

• Manage US and Global, if applicable, regulatory activities associated with advertising and promotion of marketed products and commercial development of pipeline products • Manage commercial activities from a regulatory advertising and promotion perspective with minimal guidance • 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 for compliance with applicable laws, regulations, and guidance • Collaborate with Marketing, Medical Affairs, Legal, and other key stakeholders • Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies • Help lead interactions with FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions • Maintain compliance with promotional material submissions to FDA on Form 2253 • Monitor evolving regulatory requirements related to product and disease-state communications • Monitor FDA promotional enforcement activities and advise stakeholders on their impact • Provide input on process improvements and portfolio-wide standardization of promotional review policies • Cross-train across products and indications to ensure continuous Regulatory Advertising and Promotion support • Collaborate with Regulatory Therapeutic Area Leads on marketing application summary documents and study reports • Support review cycles to reflect commercialization objectives and messages in submission documents and reports • Provide input during labeling development and negotiation to reflect commercialization objectives and messages impacting promotion and advertising

🎯 Requisitos

• Minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion • At minimum, a Bachelor’s degree from an accredited College or University in Life Sciences • Regulatory experience can offset education requirements • Advanced knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus on advertising and promotion • Experience with pharmaceutical products required; biologics experience is a plus • Experience working directly or indirectly with the FDA, specifically OPDP/APLB, preferred • Ability to review promotional materials and interact with FDA OPDP/APLB • Experience managing launch products/campaigns • Excellent written and verbal communication skills when providing strategic regulatory advice • Ability to support global promotional review • Understanding of clinical trial recruitment materials • Familiarity with labeling regulations desirable • Ability to influence cross-functional teams and interact with senior management

🏖️ 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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