Regulatory Affairs Associate (Labeling and Promotion...

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Regulatory Affairs Associate (Labeling and Promotional Review)Job ID: 1285# Positions: 1Location: US-TX-Fort WorthExperience (Years): 3Posted Date: 1/25/2010Category: ..Apply for this job:Your application choices are:* Apply for this jobonline* Refer a friend to this jobMore information about this job:Overview:Responsible for the review and sign off of all promotional and advertising materials, Rx and OTC, generated by Galderma's marketing and public relations groups to ensure Regulatory compliance.This professional plays an integral role in driving advertising and promotional review. Experience interacting with DDMAC is a must. Experience in the process that assures advertising and promotional materials meet FDA, FTC and other agency standards for marketing materials used in the pharmaceutical industry is required. Candidate must demonstrate experience and the ability to evaluate data used to support marketing claims.Responsibilities:ESSENTIAL DUTIES AND RESPONSIBILITIESOther duties may be assigned.Review and evaluate advertising and promotional materials utilized by Galderma to promote its products to consumers or to the medical community for compliance with applicable FDA, FTC and state regulations regarding such activities. This work requires:* Knowledge and understanding of FDA and FTC regulations regarding pharmaceutical and medical device company promotional activities * Knowledge and understanding of clinical statistics, evaluation of clinical and non-clinical data and how these relate to proper support for medical, commercial or statistical claims in promotion * Knowledge and understanding of PhRMA, AdvaMed and OIG codes with respect to interactions between pharmaceutical and medical device companies and healthcare professionals regarding promotion of pharmaceutical and/or medical products* Working knowledge of the appropriate methods and means of advertising and promotion of pharmaceutical and medical device products - includes print, website, etc.* Working knowledge of the laws and regulations applicable to labeling of prescription and OTC drugs, and cosmeticsMaintain up-to-date information regarding initiatives by FDA, FTC and other applicable regulatory authorities relating to the promotion of pharmaceutical, device and cosmetic productsParticipate in the review of all regulated items to ensure regulatory compliance. This includes Rx and OTC packaging and inserts, promotional pieces and websites.Coordinate with team members to anticipate and resolve any regulatory problems.Provide timely and accurate reports concerning the regulatory status of products for which this position is responsible.Qualifications:Bachelor's degree in Life Sciences from a four-year university is required with an advanced degree preferred. Minimum of three years of experience in review of clinical data in the area of review of advertising or promotion of pharmaceutical products is required. In order to function effectively, the incumbent must have a thorough working knowledge of the pharmaceutical industry including all regulatory requirements of the industry and the drug development process including pre-clinical, clinical and roduct development. Must be proficient with MS Office including Word, Excel, Outlook, PowerPoint and Access.Galderma Laboratories L.P. is an Equal Opportunity Employer (EEO) M/F/D/V