Lead Reviewer, Regulatory Affairs Advertising & Promotion

Tris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction. We have an opening for an experienced Lead Reviewer, Regulatory Affairs – Advertising & Promotion to join our Regulatory Affairs team.

Requirements

• Bachelors degree in a life-science field (advanced degree preferred)
• Minimum 4 years pharmaceutical or biotechnology industry experience reviewing promotional and non-promotional materials and submissions using the 2253 form to the FDA
• In-depth knowledge of FDA regulations, US promotional laws and industry best practices
• Proven ability to analyze complex medical and scientific information and apply regulatory principles
• Proficiency with regulatory submission tools

Benefits

• Bonus eligible
• Medical insurance
• Dental insurance
• Vision insurance
• Rx insurance
• 401K with match
• Life insurance
• Paid Company Holidays
• PTO
• Paid Volunteer Time
• Employee Resource Groups