Senior Director – Head of Regulatory Affairs

. Lead Satsuma Pharmaceuticals’ regulatory affairs and quality strategy for Atzumi TM launch readiness, U.S.

Posted 10/29/2026full-timeRemote • United StatesSenior💰 $240,000 - $300,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory affairs and quality strategy for biopharmaceutical product launches, with a strong focus on FDA compliance, lifecycle management, and cross-functional leadership. Proven ability to influence executive decision-making and manage complex regulatory processes effectively.

Highest-signal resume keywords

Regulatory Affairs LeadershipFDA Interaction ExperienceNDA Submission ManagementRegulatory Compliance KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentProduct Labeling KnowledgePost-Marketing ObligationsRegulatory Systems ManagementMarket Access Materials ReviewNDA Amendments PreparationGxP CompliancePromotional Review ProcessesLifecycle ManagementRisk Mitigation Planning

Soft Skills

Exceptional Communication SkillsOrganizational SkillsLeadership AbilitiesStrategic Vision ArticulationNegotiation Skills

Industry Keywords

Biopharmaceutical IndustryRegulatory ComplianceFDA RegulationsCommercial Product LaunchHealth-Authority CommunicationsEmerging Company EnvironmentExecutive Leadership PartnershipMarket Trends MonitoringGovernance ProcessesFunctional Strategy Alignment

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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