Senior Director – Head of Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the regulatory affairs and quality strategy for the launch readiness of Atzumi TM at Satsuma Pharmaceuticals, including U.S. commercialization and lifecycle management.

• Direct the U.S. regulatory strategy for Atzumi TM from launch preparation through commercial launch and early market activities.

• Manage functional areas via subordinate directors and managers, ensuring accountability for financial outcomes.

• Act as the senior regulatory representative during interactions with the FDA, which includes strategy for meetings, preparation of briefing documents, responding to information requests, and handling post-approval correspondence.

• Lead regulatory initiatives concerning labeling, packaging, promotional reviews, market access materials, and post-approval commitments.

• Supervise the preparation, review, and submission of NDA amendments, supplements, annual reports, and other communications with health authorities.

• Ensure adherence to FDA regulations, GxP standards, approved product labeling, and internal company policies and procedures, as well as inspection requirements.

• Collaborate with Medical Affairs, Commercial, Legal, Operations, and other departments to align regulatory and quality priorities with corporate goals and launch schedules.

• Identify regulatory risks, formulate mitigation strategies, and advise executive leadership on implications for launch, supply chain, and commercialization.

• Lead or assist in governance processes related to promotional reviews, change control, product quality, and regulatory decision-making.

• Manage post-approval regulatory maintenance and lifecycle-management projects.

• Keep abreast of regulatory requirements, FDA guidance, enforcement actions, and industry trends while providing actionable insights.

• Select, manage, and supervise external regulatory consultants, publishing vendors, and other relevant third parties.

• Anticipate market trends and strategic factors, providing guidance and direction for various functional areas.

• Collaborate with executive leadership to translate functional strategies into company-wide objectives.

• Undertake additional responsibilities, initiatives, and special projects as business needs evolve.

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory science, or a related field is required; an advanced degree is preferred.

• A minimum of 12 years of progressively responsible experience in regulatory affairs within the biopharmaceutical sector.

• Significant experience in interactions with the FDA.

• Prior experience in leading or holding a key leadership role in a first U.S. commercial product launch is highly preferred.

• Extensive knowledge of FDA regulatory standards relating to product labeling, advertising, promotion, and post-marketing obligations.

• Familiarity with ongoing regulatory compliance.

• Experience in 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.

• Capacity to operate effectively at both strategic and tactical levels.

• Exceptional written and verbal communication, organizational, and leadership abilities.

• Proficiency in articulating strategy, vision, and direction across various functions.

• Comprehensive understanding of the company, its competitive landscape, and the overall market environment.

• Capability to negotiate critical issues with internal and external executive-level management.

• Ability to partner with executive leadership to provide unified direction towards organizational goals.

• Compliance with all relevant 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