Vice President, Regulatory Affairs

🕒 Julho 7

⚔️ Virginia – Remoto

⚔️ Virginia – Remote

💵 $200.000 - $275.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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Contraline

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

⚕️ Seguro de Saúde

🌍 Impacto Social

Healthcare • Healthcare Insurance • Social Impact

A Contraline é uma empresa profundamente envolvida na prestação de serviços abrangentes de saúde mental e uso indevido de substâncias. Com foco em adultos e crianças, a Contraline oferece uma ampla variedade de serviços terapêuticos, desde sessões de terapia individual, de casais até em grupo. Ela também enfatiza o suporte comunitário e o tratamento comunitário assertivo, abordando as necessidades de avaliações psiquiátricas e gerenciamento de medicação. Seus serviços se estendem de maneira única à comunidade surda e com deficiência auditiva, a programas de alcance para pessoas sem-teto e tratamento especializado para indivíduos que experimentam psicose precoce. A Contraline integra esses esforços com serviços de cuidados de saúde física para garantir um suporte holístico. Sua missão inclui combater o estigma, compartilhar histórias transformadoras e incentivar o engajamento da comunidade em conversas sobre saúde mental.

Descrição

• Develop and execute innovative regulatory strategies that maximize development efficiency and increase probability of approval. • Serve as the primary regulatory contact with FDA for Contraline and other health authorities worldwide. • Lead all regulatory aspects of product development from preclinical stages through commercialization. • Provide strategic input when required into corporate planning, fundraising activities, business development transactions, and investor communications. • Participate in nonpromotional and promotional review as the Regulatory Affairs representative. • Build and scale the regulatory affairs function as the organization grows. • Lead preparation for regulatory agency meetings including Pre-IND, Type B, End-of-Phase 2, and Pre-NDA/BLA interactions. • Oversee preparation and submission of INDs, NDAs, BLAs, amendments, and global regulatory applications. • Provide regulatory leadership for drug-drug combination products and drug-device combination products. • Collaborate closely with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners. • Evaluate emerging regulatory risks and opportunities and provide proactive mitigation strategies. • Support diligence activities related to partnerships, licensing opportunities, and acquisitions.

🎯 Requisitos

• Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) in a relevant discipline and/or Regulatory Affairs Certification (RAC) • Minimum 15 years of regulatory affairs experience in pharmaceutical and/or biotechnology companies • Significant experience leading FDA interactions and major regulatory submissions including experience with 505(b)(2) submissions • Demonstrated success obtaining IND clearances and advancing development programs through key regulatory milestones • Experience developing regulatory strategies for innovative therapeutic products. • Strong understanding of clinical development, CMC, nonclinical development, and commercialization requirements. • Proven ability to operate effectively in entrepreneurial, resource-constrained environments.

🏖️ Benefícios

• Applicants must be authorized to work in the United States • Dedicated to building a diverse, inclusive and authentic workplace