Senior Director, Commercial Regulatory Affairs

Director/Senior Director, Regulatory Affairs Advertising and PromotionHybrid Opportunity - 3x per week onsite in Redwood City, CAMeet has partnered with an exciting rare disease biotech that is focused in the pediatric rare disease space! They are looking to bring in a Head of Regulatory Ad/Promo to support their upcoming drug launch. This will be the first in-house Ad/Promo hire for the Reg team and will report into the SVP of Regulatory Affairs.Key ResponsibilitiesYou will oversee label development for all assigned programs, managing CCDS, USPI and product characteristics summaryYou will review and approve all promotional materials, serving as a regulatory representative on the company's MRC and PRC teamYou will serve as the direct point of contact with the OPDP in support of regulatory strategy developmentKey Qualifications10+ years of experience within Commercial Regulatory AffairsScientific BS required, advanced degree (PhD, PharmD, MD) preferredRare disease experience highly preferredSmall biotech experience highly preferredPlease reach out to Ryan Moran if you're interested in learning more:?: ryan.moran@

Created: 2025-01-14