Associate Director - Global Regulatory Affairs - Product Communications

Responsibilities

• Serve as Regulatory representative for US brand and medical affairs teams
• Provide high quality, prompt regulatory advice for well-informed decision making
• Communicate regulatory expectations based on OPDP feedback and applicable laws
• Contribute to business risk mitigation strategies in advertising and medical communication
• Build and maintain relationships to influence effective communications
• Initiate promotional tactic discontinuation plans when necessary
• Counsel partners on OPDP advisory strategy and review promotional proposals

Qualifications

• Bachelor's Degree
• 3+ years of industry-related experience in drug development and/or commercialization
• Knowledge of FDA procedures and practices (CFR guidelines, guidances, etc.)
• Strong communication skills, including active listening, verbal, and written
• Demonstrated ability to influence without authority and deliver complex projects against timelines
• Recent experience reviewing advertising and promotional materials for prescription drug products
• Awareness of evolving regulatory reform initiatives and pending changes

Pay

$132,000 – $193,600 annually

Schedule

Remote - US based candidates only, no visa sponsorship available

Benefits

• Company-sponsored 401(k) and pension
• Comprehensive medical, dental, vision, and prescription drug benefits
• Flexible spending accounts for healthcare and dependent care
• Vacation benefits and time off
• Life insurance and death benefits
• Employee assistance and fitness benefits
• Eligibility for company bonus based on performance

Our Client

Equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.