Senior Manager, Regulatory Affairs

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $157.000 - $173.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

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Avalyn Pharma

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

Avalyn Pharma é uma empresa biofarmacêutica dedicada ao desenvolvimento de medicamentos inovadores voltados para o tratamento de doenças pulmonares raras. A empresa está atualmente conduzindo o Estudo MIST, um ensaio clínico de Fase 2b que avalia a segurança e eficácia de uma versão inalável da pirfenidona, conhecida como AP01, para pacientes diagnosticados com Fibrose Pulmonar Progressiva (FPP). Através de suas pesquisas, a Avalyn Pharma busca melhorar a função pulmonar e a qualidade de vida geral dos indivíduos que sofrem desta condição séria.

Descrição

• Support the development and execution of global regulatory strategies across nonclinical, clinical, CMC, and device components for Avalyn's development programs. • Translate regulatory strategy into actionable plans, timelines, and deliverables. • Identify regulatory risks and support development of mitigation strategies in partnership with senior regulatory leadership. • Provide regulatory support across multiple development programs and portfolio initiatives. • Coordinate preparation, review, and submission of regulatory filings, including INDs, CTAs, amendments, annual reports, orphan drug applications, briefing packages, and other global submissions. • Author and/or contribute to key regulatory documents and submission content. • Support Phase 3 and marketing application readiness activities. • Support regulatory meetings and interactions with FDA and other global health authorities, including preparation of responses and follow-up activities. • Ensure submissions and regulatory communications are high quality, compliant, and delivered on time. • Maintain regulatory tracking systems, dashboards, and tools used to manage submissions, commitments, correspondence, and key milestones. • Support organization and maintenance of Regulatory Affairs documentation within SharePoint and other document management systems. • Manage regulatory operational activities, including submission tracking, document management, compliance reporting, and archiving. • Monitor evolving regulatory requirements and contribute to process improvements, standards, and best practices that support compliance and operational excellence. • May serve as regulatory lead for selected routine agency interactions under senior oversight. • Work closely with Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management teams to ensure regulatory considerations are integrated into program plans. • Participate in cross-functional project teams as the regulatory representative for assigned programs and development activities. • Contribute to a collaborative and high-performing regulatory environment and provide guidance to junior team members as appropriate. • Build increasing responsibility for assigned development programs over time under the guidance of senior regulatory leadership.

🎯 Requisitos

• A minimum of a Bachelor’s degree is required; an Advanced degree (e.g., MS, PharmD, PhD, etc.) or regulatory affairs training/certification is preferred • A minimum of 5-8 plus years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product industry, with operational support of global clinical trials, and direct authorship of regulatory submissions for investigational and commercial products. • Experience supporting global development programs across one or more stages of clinical development, with hands-on preparation and maintenance of regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, and health authority meeting materials). • Working knowledge of drug-device combination products and their unique regulatory considerations is desirable. • Solid understanding of U.S. FDA regulations, ICH guidelines, and eCTD submission requirements; experience with orphan drug, expedited, or other special regulatory pathways is a plus. • Experience supporting regulatory interactions with FDA and/or other global health authorities. • Demonstrated ability to collaborate effectively within cross-functional teams, including Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management. • Strong project management, organizational, and communication skills, with demonstrated ability to manage multiple priorities and deadlines in a fast-paced environment. • Experience with regulatory information management systems, document management platforms, and/or SharePoint preferred. • Experience in a small biotechnology company or matrixed environment is desirable.