As the Regulatory Affairs Commercial Support Manager, you will:
• Conduct regulatory promotional labeling and marketing compliance reviews related to advertising & promotion of EyePoint's prescription products.
• Conduct Regulatory compliance reviews as a member of a multi-disciplinary Product Review Committee, consisting of Regulatory, Legal, Medical and Commercial, in the review of strategies, activities & communications.Participate in Global Regulatory Functional Teams, Product Labeling Teams and Compound Development Teams.
• Integrate compliance considerations into product team project development.
• Provide input for policies, procedures and training related to Regulatory Advertising & Promotion and marketing compliance.
• When appropriate, serve as primary contact for Office of Prescription Drug Promotion (OPDP) at FDA for assigned product related new product launches, and for the timely submission of promotional materials to OPDP.
• Identify issues and help to develop alternatives to avoid any misperception in the respective communication while achieving the desired communication outcomes.