Senior Director – Head of Regulatory Affairs

🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $240.000 - $300.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 23%

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Satsuma Pharmaceuticals, Inc.

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11 - 50 funcionários

Fundada em 2016

💊 Farmacêutico

🧬 Biotecnologia

Pharmaceuticals • Biotechnology

A Satsuma Pharmaceuticals, Inc. é uma empresa farmacêutica focada no desenvolvimento e na comercialização de terapias para enxaqueca por meio de sua plataforma de drug delivery SMART (Simple MucoAdhesive Release Technology). Seu primeiro produto aprovado, Atzumi™ (STS101), é um pó nasal de di-hidroergotamina (DHE) indicado para o tratamento agudo da enxaqueca, com ou sem aura, em adultos. A empresa destaca publicações e apresentações clínicas e enfatiza a maior eficácia e praticidade de administração proporcionadas por sua abordagem de drug delivery nasal mucoadesivo.

Descrição

• Lead Satsuma Pharmaceuticals’ regulatory affairs and quality strategy for Atzumi TM launch readiness, U.S. commercialization, and lifecycle management • Lead the U.S. regulatory strategy for Atzumi TM through launch readiness, commercial launch, and early commercialization • Direct functional areas through subordinate directors and managers and remain accountable for function financial results • Serve as the senior regulatory representative in FDA interactions, including meeting strategy, preparation, briefing documents, information-request responses, and post-approval correspondence • Lead regulatory activities for labeling, packaging, promotional review, market access materials, and post-approval requirements and commitments • Oversee preparation, review, and submission of NDA amendments, supplements, annual reports, and other health-authority communications • Ensure compliance with FDA regulations, GxP requirements, approved product labeling, company policies and procedures, and inspection expectations • Partner with Medical Affairs, Commercial, Legal, Operations, and other functions to align regulatory and quality priorities with corporate objectives and launch timelines • Identify regulatory risks, develop mitigation plans, and advise executive leadership on effects on launch, supply, and commercialization • Lead or support governance processes for promotional review, change control, product quality, and regulatory decision-making • Oversee post-approval regulatory maintenance and lifecycle-management initiatives • Monitor regulatory requirements, FDA guidance, enforcement activity, and industry trends and provide actionable recommendations • Select, manage, and oversee external regulatory consultants, publishing vendors, and other third parties • Anticipate market and strategic factors and provide strategy and direction for multiple functional areas • Partner with executive leadership to cascade functional strategy into company-wide objectives • Execute additional responsibilities, initiatives, and special projects as business needs evolve

🎯 Requisitos

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory science, or a related discipline required; advanced degree preferred • 12+ years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry • Substantial experience interacting with the FDA • Prior experience leading, or serving in a significant leadership role, a first U.S. commercial product launch strongly preferred • In-depth knowledge of FDA regulatory requirements governing product labeling, advertising and promotion, and post-marketing obligations • Knowledge of ongoing regulatory compliance • Experience establishing, scaling, or managing regulatory systems and processes in a small, emerging, or resource-efficient company environment • Ability to influence executive-level decision-making and lead complex cross-functional initiatives • Ability to operate effectively at strategic and tactical levels • Exceptional written and verbal communication, organizational, and leadership skills • Ability to articulate strategy, vision, and direction across multiple functions • Comprehensive understanding of the overall company and competitive environment • Ability to negotiate critical matters with internal and external executive-level management • Ability to partner with executive leadership to provide cohesive direction toward company goals • Compliance with applicable work authorization and employment eligibility requirements

🏖️ Benefícios

• Health Insurance • Dental & Vision Insurance • Healthcare & Dependent Care FSA • Employee Assistance Program (EAP) • 401(k) Savings Plan • Long-term Incentive Plan • Life Insurance • Accident & Disability Insurance • Telemedicine • Generous Paid Time Off • Company Holidays

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