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| Biotech Regulatory Affairs CA Open (J#28492) Title: Biotech Regulatory Affairs Company: MRINetwork Job Category: Biotech/R&D/Science DDMAC Expert needed! A mid-size, high growth biotech company is expanding its Regulatory Affairs department and has a need for a Regulatory Affairs Manager specializing in DDMAC initiatives. This is a 10-year old organization that commercialized our first product in only our fourth full year of business and achieved profitability shortly after that. We specialize in the discovery and development of breakthrough therapies for cardiovascular and pulmonary disease and will be launching three new products over the next four years. With sales revenue soaring, they are expanding rapidly. This remarkably rapid growth rate, virtually unheard of in the biotech industry, has led to the need to expand the Regulatory Affairs group. Responsibilities: The Manager will work full time with the sales and marketing organization to ensure compliance in advertising and promotional programs. This is a high-profile position where you will have the opportunity to create, implement and enforce compliance procedures for all marketing messages, physician advisory boards and medical education programs. You will also help prepare regulatory submissions for FDA and negotiate with DDMAC for approval of promotional messages. Another important duty is the regulatory review of requests for investigator initiated study funding and grant requests. More... | |||
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