Senior Director – Head of Regulatory Affairs

Job not on LinkedIn

🕒 4 days ago

🇺🇸 United States – Remote

💵 $240k - $300k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Satsuma Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2016

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Satsuma Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing therapies for migraine using its SMART (Simple MucoAdhesive Release Technology) drug-delivery platform. Its first approved product, Atzumi™ (STS101), is a dihydroergotamine (DHE) nasal powder indicated for the acute treatment of migraine with or without aura in adults. The company highlights clinical publications and presentations and emphasizes improved efficacy and administration via its mucoadhesive nasal delivery approach.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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