What are the responsibilities and job description for the Associate Director, Regulatory Affairs, Advertising & Promotion position at Proclinical Staffing?
Associate Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA
Proclinical is seeking an Associate Director, Regulatory Affairs, Advertising & Promotion for a global pharmaceutical company with their location in New Jersey.
Primary Responsibilities:
In this role, you will review, approve and monitor prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements.
The position will be based at their New Jersey site in a hybrid work schedule.
Skills & Requirements:
- Bachelor’s degree required. Science or health related discipline preferred. (Advanced degree [PhD, MD, MS, PharmD] preferred)
- Minimum of 8 years of relevant pharmaceutical industry experience with 4 years of relevant prescription product advertising and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
The Associate Director, Regulatory Affairs, Advertising & Promotion will:
- Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
- Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.
- Monitors FDA activity including enforcement actions, guidance documents, etc. to analyze and assess impact on company products and communicates risk to PRC(s).
- Monitors competitor advertising to keep abreast of market promotional and advertising strategies and assesses potentially violative competitive materials for forwarding to the FDA Office of Prescription Drug Promotion (OPDP) or Advertising and Promotion Labeling Branch (APLB) as appropriate.
- Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at ( 1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
