Regulatory Affairs & Quality Leader for US Launch

Satsuma Pharmaceuticals, Inc.; United States; Presencial; USD 240 000 - 300 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

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

Paid Time Off

Company Holidays

Resumo da oferta

Satsuma Pharmaceuticals, Inc. is seeking a senior regulatory affairs and quality leader to guide the U.S. launch readiness for AtzumiTM and lifecycle management.

This role directs FDA interactions and ensures full regulatory and quality compliance across the organization. The position oversees QA activities, labeling, promotional reviews, and post-approval commitments, while partnering with cross-functional teams to align regulatory priorities with commercial goals.

Qualificações

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory science, or a related discipline required; advanced degree preferred.
• 12+ years of progressively responsible regulatory affairs and quality experience, including substantial FDA interaction experience.
• Prior experience leading a first U.S. commercial product launch is strongly preferred.
• In-depth knowledge of FDA regulatory requirements governing labeling, advertising, and post-marketing obligations.
• Experience establishing or managing regulatory and quality systems in a small or resource-efficient company.
• Proven ability to influence executive-level decisions and lead cross-functional initiatives.
• Exceptional written and verbal communication, organizational, and leadership skills.

Responsabilidades

• Lead the U.S. regulatory strategy through launch readiness, commercial launch, and early commercialization.
• Serve as the company’s senior regulatory representative in FDA interactions and post-approval correspondence.
• Provide leadership and oversight of the Quality Assurance function, including contract manufacturers and suppliers.
• Lead regulatory activities critical to product launch and commercialization, including labeling and market access materials.
• Oversee preparation and submission of high-quality regulatory filings (NDA amendments, supplements, annual reports).
• Ensure ongoing compliance with FDA regulations, GxP, labeling, and company policies.
• Partner with Medical Affairs, Commercial, Legal, Operations, and others to align regulatory priorities with launch timelines.
• Identify regulatory/quality risks and advise executive leadership on impact on launch and commercialization.
• Lead or support governance processes related to promotional review, change control, and product quality.

Conhecimentos

Regulatory strategy

FDA interactions

Leadership

Quality systems

Cross-functional collaboration

Excellent communication

Strategic thinking

Formação académica

Bachelor’s degree in life sciences/related

Advanced degree preferred

Ferramentas

Regulatory submissions

Descrição da oferta de emprego

Satsuma Pharmaceuticals, Inc. is seeking a senior regulatory affairs and quality leader to guide the U.S. launch readiness for AtzumiTM and lifecycle management.

This role directs FDA interactions and ensures full regulatory and quality compliance across the organization. The position oversees QA activities, labeling, promotional reviews, and post-approval commitments, while partnering with cross-functional teams to align regulatory priorities with commercial goals.