Role Senior Specialist Regulatory Pharmacologist - Promotions, overseeing review and approval of US promotional materials for immunotherapy and biologics products, contributing to regulatory strategies and ensuring compliance with FDA regulations.
Responsibilities:
Manage FDA promotional correspondence. Develop regulatory strategies for marketing campaigns. Support US commercial teams with regulatory guidance. Maintain current knowledge of industry regulations.
Requirements:
Bachelor's degree in science or healthcare with 7+ years of industry experience, or advanced degrees with fewer years. Experience as primary reviewer of promotional materials. Strong knowledge of FDA advertising regulations, pharmacology, immunology, or oncology preferred. High-Value Focus on biologics/immunotherapy (e.g., FDA Breakthrough Therapy). Promotional review, regulatory strategy, cross-functional collaboration with marketing, legal, medical teams. Work Setup Onsite in Southern California. Regular weekday schedule. Close interaction with scientific teams. Physical ability to work at a desk and lift materials up to 20 pounds.
