Senior Director, Head of Regulatory Affairs and Quality

Satsuma Pharmaceuticals

10d•$240,000 - $300,000

About The Position

Satsuma Pharmaceuticals is a biopharmaceutical company preparing to launch AtzumiTM (dihydroergotamine (DHE) nasal powder), a novel therapeutic product approved in the US for the acute treatment of migraine. AtzumiTM incorporates proprietary advanced powder and device technology (SMART – Simple MucoAdhesive Release Technology™) and is designed to be easy-to-use, easy-to-carry, and for quick self-administration. This role is responsible for leading Satsuma Pharmaceuticals’ regulatory affairs and quality strategy to support AtzumiTM launch readiness, U.S. commercialization, and lifecycle management. This role is responsible for directing interactions with the FDA, maintaining company-wide compliance with applicable regulatory and quality requirements, and partnering cross-functionally to ensure successful product launch and ongoing commercial support.

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 and quality within the biopharmaceutical industry, including substantial experience interacting with the FDA.
In-depth knowledge of FDA regulatory requirements governing product labeling, advertising and promotion, and post-marketing obligations, and ongoing regulatory compliance.
Demonstrated experience establishing, scaling, or managing regulatory and quality systems and processes in a small, emerging, or resource-efficient company environment.
Proven ability to influence executive-level decision-making, lead complex cross-functional initiatives, and operate effectively at both strategic and tactical levels.
Exceptional written and verbal communication, organizational, and leadership skills.

Nice To Haves

Prior experience leading, or serving in a significant leadership role, a first U.S. commercial product launch is strongly preferred.

Responsibilities

Lead the U.S. regulatory strategy for AtzumiTM through launch readiness, commercial launch, and early commercialization.
Serve as the company’s senior regulatory representative in FDA interactions, including meeting strategy and preparation, briefing documents, responses to information requests, and post-approval correspondence.
Provide leadership and oversight of the Quality Assurance function, including contract manufacturers and suppliers, product disposition and release, deviations, corrective and preventative actions, change control, complaints, annual product quality reviews, document control, training, audits, and inspection readiness.
Lead regulatory activities critical to product launch and commercialization, including labeling, packaging, promotional review, market access materials, and fulfillment of post-approval requirements and commitments.
Oversee preparation, review, and submission of high-quality regulatory filings, including NDA amendments, supplements, annual reports, and other communications with health authorities.
Ensure ongoing compliance with applicable FDA regulations, GxP requirements, approved product labeling, company policies and procedures, and regulatory inspection expectations.
Partner closely with Medical Affairs, Commercial, Legal, Operations, and other functions to align regulatory and quality priorities with corporate objectives and launch timelines.
Identify and assess regulatory and quality risks, develop appropriate mitigation plans, and advise executive leadership regarding potential effects on product launch, supply, and ongoing commercialization.
Lead or support cross-functional governance processes related to promotional review, change control, product quality, and regulatory decision-making.
Oversee post-approval regulatory maintenance and support lifecycle-management initiatives, including potential line extensions, formulation or device changes, and additional indications, as applicable.
Monitor evolving regulatory requirements, FDA guidance, enforcement activity, and industry trends, and translate relevant developments into clear, actionable recommendations for the organization.
Select, manage, and oversee external regulatory consultants, publishing vendors, quality service providers, and other third parties as needed in a lean operating environment.