Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling

📋 Description

• Lead promotional and medical review: Serve as the regulatory lead for promotional and medical
• Guide promotional strategy: Provide proactive regulatory advice on advertising, promotional, and
• Manage health authority interactions: Lead engagements with the U.S. Food and Drug Administration's
• Drive labeling strategy: Direct the development and maintenance of core, U.S., and patient
• Support global regulatory alignment: Collaborate with Global Regulatory Leads on labeling
• Oversee labeling implementation: Develop and execute global implementation plans that incorporate

🎯 Requirements

• Bachelor's or master's degree with relevant professional experience; an advanced life sciences or
• At least 8 years of biopharmaceutical regulatory affairs experience, including a minimum of 6 years
• Expert knowledge of FDA promotional regulations, product labeling requirements
• Demonstrated experience supporting product launches and lifecycle management, ideally within a
• Strong understanding of promotional and non-promotional communications, claims substantiation, fair
• Experience developing and maintaining core and local product labeling, coordinating global

🎁 Benefits

• Annual base salary: $180,000–$205,000 USD.
• Annual bonus: Eligible for an annual performance bonus.
• Equity compensation: Eligible for equity awards and participation in the company's stock plan.
• Work arrangement: Remote position within the United States, with West Coast hours preferred.
• Employment type: Full-time.
• Compensation flexibility: Final salary may vary based on experience, education, geographic