Senior Director, Commercial Regulatory Affairs at Meet in San Jose, California

Posted in Other about 22 hours ago.

Type: full-time





Job Description:

Director/Senior Director, Regulatory Affairs Advertising and Promotion

Hybrid Opportunity - 3x per week onsite in Redwood City, CA

Meet 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 Responsibilities
  • You will oversee label development for all assigned programs, managing CCDS, USPI and product characteristics summary
  • You will review and approve all promotional materials, serving as a regulatory representative on the company's MRC and PRC team
  • You will serve as the direct point of contact with the OPDP in support of regulatory strategy development

Key Qualifications
  • 10+ years of experience within Commercial Regulatory Affairs
  • Scientific BS required, advanced degree (PhD, PharmD, MD) preferred
  • Rare disease experience highly preferred
  • Small biotech experience highly preferred

Please reach out to Ryan Moran if you're interested in learning more:

?: ryan.moran@meetlifesciences.com
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