The role will be an internal expert on the US FDA regulations, guidelines and trends governing the promotion of prescription products including gene therapies. Leads regulatory review and approval for promotional, medical education and corporate materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies and best practices. Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues. Serve as the company's primary liaison with FDA’s APLB, including advisory comments, voluntary submissions and responses to inquiries for respective product(s) and ensures materials are submitted to FDA via 2253. Demonstrated leadership skills in highly matrixed environments.
Create an account to see the full posting, access our search engine, and more.You're just 60 seconds away from your new Creativeloft account.