Senior Director, Regulatory Affairs

🕒 Setembro 25

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 20%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Pulmovant

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

Healthcare • Consulting • Food & Beverage

A Pulmovant é uma empresa comprometida em transformar a vida de pacientes com doenças pulmonares por meio do desenvolvimento de terapias inovadoras. Seu principal produto, o mosliciguat, tem como objetivo fornecer um tratamento inalável, de uso único diário, para hipertensão pulmonar, caracterizado por seu mecanismo inovador de ativação de sGC. Com um foco singular em atender às necessidades únicas de pacientes que sofrem de condições pulmonares, a Pulmovant está engajada em extensos ensaios clínicos para avançar suas opções de tratamento pioneiras.

Descrição

• Provide global regulatory strategy and support as a member of multidisciplinary teams • Manage regulatory processes from development through approval and ensure compliance with US and international regulatory requirements • Represent Regulatory Affairs in project meetings and provide regulatory guidance to cross-functional teams • Serve as regulatory affairs contact for external parties, including CROs and advisors, involved in global clinical trials • Develop and implement global regulatory strategies for clinical-trial submissions and registration under applicable regulations and guidelines, including US FDA, EMA, PMDA, ICH, and ISO • Plan, prepare, author, and/or review IND, CTA, BLA, NDA, and MAA submissions and related documentation • Liaise with global health authorities • Contribute to regulatory strategies that expedite development, maximize success probability, and mitigate risks • Communicate project updates and risks to senior regulatory affairs management and organizational stakeholders • Track regulatory commitments and deliverables and coordinate internal and external staff for timely submissions • Coordinate and prepare responses to health-authority information requests • Prepare meeting requests and briefing documents and coordinate teams for health-authority meetings • Provide input into regulatory policies and procedures aligned with GxPs, guidance documents, and corporate objectives • Monitor, analyze, and disseminate regulatory intelligence affecting development programs • Participate in due diligence evaluations of potential in-license and partnering opportunities

🎯 Requisitos

• Education equivalent to a BS degree in a scientific field, plus 15+ years of experience in regulatory affairs; or education equivalent to an MS degree in a scientific field, plus 12-15 years of experience in regulatory affairs; or education equivalent to a PhD/PharmD degree in a scientific field, plus 8 years of experience in regulatory affairs • Recent experience leading the preparation, submission and approval process for an NDA • Experience working with the FDA is essential • Additional experience with EU, Japan and other global health authorities is strongly preferred • Experience interacting with the FDA Division of Cardiology and Nephrology strongly preferred • Experience with pulmonary hypertension and other pulmonary diseases a plus • Experience in drug/device combination products a plus • Regulatory Affairs Certification (RAC) in drugs and/or devices a plus • Excellent verbal, written, communication, interpersonal, presentation, and collaboration skills • Ability to multitask in a fast-paced environment and work under pressure while meeting time-sensitive deadlines • Ability to work across locations and time zones • Highly proficient in Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint or similar applications and systems; Veeva experience a plus • Strong financial business acumen and analytical skills, including managing expenditures within budget • Ability to travel up to 10%

🏖️ Benefícios

• Equal employment opportunities and protection from discrimination and harassment • Travel up to 10% may be required to meet with vendors and regulators