Senior Director – Head of Regulatory Affairs

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

📋 Description

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

• Oversee the U.S. regulatory strategy for Atzumi TM through the stages of launch readiness, commercial launch, and early commercialization.

• Manage functional areas via subordinate directors and managers while remaining accountable for financial outcomes.

• Act as the senior regulatory representative during FDA interactions, including strategy formulation for meetings, preparation of briefing documents, responses to information requests, and post-approval correspondence.

• Direct regulatory activities concerning labeling, packaging, promotional reviews, market access materials, and post-approval requirements and 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 requirements, approved product labeling, company policies, procedures, and inspection expectations.

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

• Recognize regulatory risks, formulate mitigation plans, and counsel executive leadership on impacts to launch, supply, 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 initiatives.

• Stay informed on regulatory requirements, FDA guidance, enforcement activities, and industry trends, providing actionable recommendations.

• Select, manage, and oversee external regulatory consultants, publishing vendors, and other third-party resources.

• Anticipate market and strategic factors, offering strategic direction for multiple functional areas.

• Collaborate with executive leadership to translate functional strategy 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; advanced degree preferred.

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

• Significant experience interacting with the FDA.

• Prior experience in a leadership role during the first U.S. commercial product launch is highly preferred.

• Extensive knowledge of FDA regulatory requirements concerning 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.

• Capability to influence executive-level decision-making and lead complex cross-functional initiatives.

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

• Outstanding written and verbal communication, organizational, and leadership skills.

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

• Thorough understanding of the overall company and competitive landscape.

• Competence in negotiating critical matters with internal and external executive-level management.

• Ability to work in partnership with executive leadership to provide unified direction towards company objectives.

• Compliance with 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