Director, Regulatory Affairs – Advertising, Promotion and Labelling

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🕒 Outubro 8

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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• Aberta há 33 dias.
• As vagas desta empresa costumam ser preenchidas em 41 dias.
• Sem salário divulgado.

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Autolus Therapeutics

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2014

🏥 Saúde

💼 Consultoria

🏭 Manufatura

💰 $350.000.000 Post-IPO Equity - Autolus em 2024-02

Healthcare • Consulting • Manufacturing

A Autolus Therapeutics é uma empresa de biotecnologia em estágio clínico que desenvolve terapias de células CAR T autólogas de próxima geração para câncer e doenças autoimunes. A empresa aplica programação celular avançada, vetores virais proprietários e manufatura semiautomatizada de células T para criar produtos CAR T de precisão, avançando em um pipeline que inclui programas para malignidades hematológicas, tumores sólidos e indicações autoimunes. A Autolus enfatiza esforços integrados de desenvolvimento e comercialização, ensaios clínicos e publicação de suas pesquisas.

Descrição

• Develop and implement regulatory strategies for advertising, promotion, and medical communications • Lead interactions with FDA OPDP/APLB regarding promotional and medical communications • Interpret applicable regulatory guidance, regulations, and precedents • Support and implement the Promotional and Medical Communications Material Review Process using Veeva PromoMats • Advise on compliant product messages and materials across functional areas • Lead timely regulatory review and approval of US promotional and medical communications • Contribute to material review meetings • Prepare and submit regulatory documents, including Form 2253, to OPDP/FDA • Collaborate with Commercial, Marketing, Medical Affairs, Legal, Compliance, Regulatory Affairs, and other stakeholders • Foster regulatory compliance and excellence • Provide training on FDA requirements, PhRMA DTC Guidelines, and the company materials review process • Lead global labelling strategy and development for assigned products, including TPLs, CCDS, USPI, SmPC, and related core labelling documents • Serve as global labelling subject matter expert • Chair cross-functional labelling governance processes • Ensure global, regional, and local labelling remains aligned and compliant with clinical, safety, and manufacturing data • Partner with Regulatory Affairs, Supply Chain, Manufacturing, and other functions on submission-ready labelling and regulatory filings • Identify and mitigate labelling risks and resolve complex labelling issues • Develop strategic responses to labelling-related Health Authority questions • Create, improve, and update departmental or cross-functional processes and SOPs • Attend occasional domestic and international business-critical meetings/events

🎯 Requisitos

• Minimum of 15 years of experience in the pharmaceutical industry • At least 10 years as a Regulatory Advertising and Promotion professional • At least 6 years of strategic labelling experience • Solid understanding of the structure and function of product labelling • Strong scientific background and ability to interpret scientific documents and concepts • Knowledge of global standards and regulations related to CCDS and product labelling • USPI and EU SmPC experience required • Ability to guide cross-functional labelling teams, including senior management • Understanding of medical concepts and terminology • Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, products, therapeutic knowledge, and evidentiary standards for product claims • Demonstrated business acumen and understanding of company objectives • Proven ability to identify issues and develop risk mitigation strategies • Excellent oral and written communication, project management, and presentation skills • Ability to negotiate persuasively and address disagreements constructively • Track record of handling critical issue situations effectively • Expert in Veeva PromoMats • Strong computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, Teams, and Adobe Acrobat • BA/BS in a scientific discipline • Must be based in US-New Jersey (Remote)

🏖️ Benefícios

• Flexible, diverse and dynamic working environment • Inclusive and fair workplace • Reasonable accommodations throughout the recruitment process • Professional development and investment in people • Occasional domestic and international business travel opportunities

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