The Associate Director, Regulatory Affairs will be responsible for the regulatory review and approval of all labeling, based on development and management of a target product profile (TPP). They will oversee and coordinate the regulatory review and approval of all commercial materials through the Promotional Review Committee (PRC) and interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products. In addition, this position oversees all regulatory operational management of commercial materials (Veeva Vault – electronic document management system, applicable processes and SOPs and will w
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