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Associate Director, Regulatory Affairs

Southport, CT 06890

Posted: 09/07/2023 Category: Pharmaceutical Job Number: 283102-1_1 Salary: 185,000

Job Description

Smith Hanley Associates
Associate Director, Regulatory Affairs (Advertising & Promotion)
Nihar Parikh [email protected]

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.

Advanced degree in Health Sciences or related discipline.
7+ 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.

Meet Your Recruiter

Nihar Parikh
Executive Recruiter

Nihar specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech. He has more than ten years of recruiting experience and attributes his success to the ability to build good relationships, listen attentively, be proactive, continuously self-improve, and show empathy. Nihar plans to carry Smith Hanley’s stellar reputation in the pharma business for many years to come. Outside of work, Nihar likes to spend his time following Chicago sports, travel, podcasts, yoga, golf, and investing. 

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