Senior Manager Regulatory Affairs

Smith Hanley Associates

Senior Manager, Regulatory Affairs (Advertising & Promotion)

Remote/Permanent

Nihar Parikh – [email protected]

Responsibilities:

Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies.

Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and policies.

Monitors FDA activity including enforcement actions, guidance documents, etc. to analyze impact on products.

Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.

Monitors competitor advertising to keep abreast of market promotional and advertising strategies.

Continually assesses the advertising and promotion related process to enhance efficiencies and compliance, and assist with ongoing regulatory training related to prescription drug products.

Works closely with the Regulatory Affairs prescription drug product labeling group in order to assess and determine the impact of proposed labeling changes on product promotion.

Requirements:

Advanced degree in Health Sciences or related discipline.

5+ years of pharmaceutical experience with 3+ years of pharmaceutical advertising and promotion experience.

Knowledge of the pharmaceutical industry, Regulatory Affairs for prescriptions drugs.

Detail-oriented with the ability to proofread and check documents for accuracy as well as consistency.

Knowledge of the pharmaceutical product NDA and labeling processes.

Strong interpersonal skills with the ability to influence others.

www.smithhanley.com