Associate Director Regulatory Affairs Advertising and Promotion

Profile

Associate Director, Regulatory Affairs Advertising and Promotion

the candidate serves as a primary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams. May include a launch product or indication with manager oversight. Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H with manager oversight. Establishes strong and positive working relationship with OPDP reviewers. Manages OPDP queries on assigned products. Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to US promotional issues. Ensures regulatory compliance while effectively managing business risks. Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted. Prepares complaint letters to OPDP with manager oversight. Conducts reviews of materials to be used by medical personnel in discussions with customers. Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by the attendance of major FDLI, DIA and other industry/FDA meetings. Collaborates with Regulatory Affairs colleagues to provide input to study designs or US label regarding the feasibility of promoting potential data/claims with manager oversight. Participates/assists in US labeling negotiations and FDA meetings as necessary. Ensures that changes in US Prescribing Information are reflected in the current promotion and advertising.

Additional Information

ID: 354764BR.

Company info

Novartis Pharmaceuticals Corporation.
One Health Plaza
East Hanover
New Jersey
United States 07936-1080
Website : http://www.pharma.us.novartis.com