Full-Time

Associate Director/Director

Regulatory Affairs Advertising & Promotion

Confirmed live in the last 24 hours

Axsome Therapeutics Inc

Axsome Therapeutics Inc

501-1,000 employees

Develops therapies for central nervous system conditions

Biotechnology

Compensation Overview

$160k - $185kAnnually

+ Bonus + Equity

Senior

New York, NY, USA

Requirements
  • BS life sciences degree or equivalent required
  • 7+ years in the drug development industry with at least 3 years in Regulatory Affairs Advertising and Promotion
  • Ability to work on site Monday, Tuesday & Thursday
Responsibilities
  • Independently review advertising and promotional labeling materials
  • Prepare and sign FDA Form 2253 for promotional labeling advertising submissions
  • Lead submission of promotional materials for FDA advisory comment
  • Analyze and interpret new regulations and FDA guidance documents
  • Communicate changes in FDA perspective to stakeholders
  • Support US Commercial teams in strategy discussions and labeling negotiations
  • Identify regulatory compliance vulnerabilities and risks
  • Provide training on advertising and promotion regulations
  • Collaborate with other functions on policy and procedure development
  • Develop documents related to product labeling in promotion and advertising
Axsome Therapeutics Inc

Axsome Therapeutics Inc

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With a dedicated focus on developing therapies for central nervous system conditions—such as depression, Alzheimer’s disease agitation, and fibromyalgia—this company stands out by addressing critical unmet medical needs with promising products like AXS-05 and AXS-07. The firm fosters a culture deeply committed to innovation and the development of therapies with novel mechanisms of action, showcasing strong potential in the medical field and enhancing patient care in areas with limited treatment options.

Company Stage

IPO

Total Funding

$430.7M

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

11%

1 year growth

44%

2 year growth

277%