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← Praxis Precision Medicines, Inc.

Associate Director, Regulatory Affairs, AD Promo

Praxis Precision Medicines, Inc.
Location
United States - Remote
Posted
16 days ago
Department
Regulatory
What they actually want (must-haves)
  • Bachelor's degree in a scientific, pharmacy, health-related, or relevant discipline
  • 8+ years of pharmaceutical or biopharmaceutical industry experience
  • At least 5 years focused on regulatory advertising and promotion
  • Deep knowledge of FDA requirements and guidance for prescription drug advertising and promotion
  • Experience with Form FDA 2253 submissions and OPDP interactions
  • Demonstrated experience reviewing promotional materials across various channels
Nice to have
  • Advanced degree such as a PharmD, MS, PhD, MD, or JD
  • Experience supporting product launches and PAIE activities
  • Experience in CNS, neurology, or rare disease
  • Familiarity with Veeva PromoMats, RIM, or comparable systems
What the job really is

The Associate Director of Regulatory Affairs for Advertising & Promotion will lead regulatory review and approval of promotional materials for Praxis, ensuring compliance with FDA regulations. The role involves collaboration with multiple departments to shape campaigns, manage FDA submissions, and improve promotional processes, all while exercising strong regulatory judgment and maintaining effective communication across teams.

Benefits
  • 99% of the premium paid for medical, dental and vision plans
  • Company-paid life insurance, AD&D, disability benefits
  • 401(k) matching dollar-for-dollar up to 6%
  • Long-term stock incentives and ESPP
  • Discretionary quarterly bonus
  • Flexible wellness benefit
Things to weigh
  • Remote position with required travel flexibility
  • High visibility role requiring strong regulatory judgment and decision-making in a fast-paced environment
Job score3.4/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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