Head of Global Regulatory Advertising and Promotion
Core
Leading global post-marketing regulatory activities for Sobi's pharmaceutical products, ensuring FDA compliance for promotional materials and managing the global review process.
Role type
Senior leadership regulatory affairs executive (Head of Global Regulatory Advertising & Promotion)
Builds
FDA-compliant promotional and medical communications for rare disease therapeutics
Domain
Biopharmaceuticals / Rare Diseases / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA advertising and promotion regulations, strategic leadership, regulatory risk assessment, cross-functional collaboration, SOP development, therapeutic knowledge (Hematology/Oncology)
Preferred skills
PhD/MD/PharmD/JD, Rare Diseases experience, advanced AI digital tools proficiency
Technologies
FDA OPDP/APLB systems, AI digital tools
Responsibilities
Lead and direct post-marketing regulatory activities for marketing of Sobi products, own the Sobi Global Material review process, lead interactions with FDA Office of Product Prescription and Drug Promotion, develop and lead departmental strategic initiatives, serve as strategic partner on regulatory risk assessment, oversee the adpromo team in assessing regulatory context, provide regulatory advice on global promotional materials, lead development of SOPs and Work Instructions
Seniority
Executive, hands-on leader with 6+ direct reports
