Responsibilities

• US Regulatory Review & Compliance
• Lead regulatory review and approval of U.S. product promotional materials.
• Ensure product claims are supported by FDA-approved labeling and are scientifically substantiated
• Serve as the regulatory advertising and promotion subject matter expert for the organization
• Influence cross-functional decision making through strategic regulatory guidance.
• Mentor junior regulatory professionals and contribute to talent development initiatives
• Lead continuous improvement efforts related to promotional review processes and governance
• Represent regulatory on the MLR Committee, and provide strategic regulatory input during new concept reviews, and review and approve materials for regulatory compliance
• Review non-promotional assets, including medical, corporate affairs, market access/payor communications, and patient advocacy materials
• Develop and update Important Safety Information (ISI) and risk presentations for use in commercial assets for target audiences

Requirements

• Bachelor’s degree
• Preferred: PharmD, PhD, or JD
• Minimum 10 years in pharmaceutical or biotechnology regulatory affairs
• At least 7 years focused on US advertising and promotion
• Proven track record of successful launches for drug or biologic products
• Direct history of managing interactions and submissions with OPDP
• Expert knowledge of FDA regulations governing biologics and promotional compliance
• Proficiency with electronic review systems, specifically Veeva Vault PromoMats
• Ability to interpret complex clinical data into compliant marketing messages
• Excellent written and verbal communication skills with executive-level stakeholders

Benefits

• equity in the form of stock options and/or restricted stock units
• comprehensive health, dental, vision, life and disability insurance coverage
• 401k retirement benefits with employer match
• learning and wellness stipends
• paid time off