Biotechnology, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned products.
Help ensure compliant commercial growth under applicable laws, regulations, guidelines, and company policies.
Strategically support the business and address problems/opportunities by generating alternatives to achieve desired outcomes.
As a Director, Regulatory Promotional Compliance 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.
A minimum of a Bachelor’s degree in a healthcare or science related field is required.
An advanced degree (PhD, Pharm D, JD, MBA, etc.) is desired.
A minimum of 10 years of regulatory experience is required.
Regulatory advertising and promotion experience in pharmaceutical and/or biopharmaceutical industry is required.
Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required.
Demonstrated ability with complex problem solving; excellent written and verbal communications are required.
Must be able to work out of the Watertown, MA office with travel up to 10%, mainly to domestic destinations.
Experience with Veeva Systems, or similar industry related systems.
Internal Number: 2019
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company has developed 5 FDA-approved sustained-release treatments in ophthalmology.