Manager, Regulatory Affairs, Advertising & Promotion

🕒 Outubro 24

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $128.600 - $210.000 / 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

• Manage US regulatory activities associated with advertising and promotion of the company’s marketed products • Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director • Contribute to and advise on the development of product messages and materials across multiple functional areas • Provide regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibit activities, 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 • Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies • Help lead and assist in interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions • Maintain effective communication with FDA OPDP reviewers on advertising and promotion matters • Ensure compliance with promotional material submissions to FDA on Form 2253 • Monitor the external environment and advise product teams on evolving regulatory requirements • Monitor FDA promotional enforcement activities and update stakeholders • Provide guidance on the impact of enforcement activities on company policies • Identify process improvements for promotional review activities and portfolio-wide policy standardization • Cross-train across products and indications to ensure continuous Regulatory A&P support • Collaborate with Regulatory Therapeutic Area Leads to review marketing application summary documents and study reports • Provide input during review cycles to reflect commercialization objectives and messages in submission documents and reports • Provide input during labeling development and negotiation regarding commercialization objectives and messages impacting promotion and advertising

🎯 Requisitos

• A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion • At minimum, a Bachelor's degree from an accredited college or university in Life Sciences • Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion • Experience with pharmaceutical products required; biologics experience is a plus • Experience working directly/indirectly with the FDA, specifically OPDP/APLB, is preferred • Ability to review promotional materials and interact with FDA OPDP/APLB • Ability to support launch products/campaigns while maintaining excellent written/verbal communication skill when giving strategic regulatory advice • Ability to support global promotional review • Understanding of clinical trial recruitment materials • Familiarity with labeling regulations is desirable • Ability to influence cross-functional teams and work collaboratively with colleagues at all levels • Ability to interact with senior management if needed

🏖️ 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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