Regulatory Job Assoc Dir of Reg Affairs

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Assoc Dir of Reg Affairs NJ Open (J#11335)
Education: Bachelors Degree

Depending on level, this regulatory affairs professional may function as the DRA representative responsible for assuring the regulatory integrity of assigned investigational and marketed products. At higher level, this associate is also the primary liaison between Company and the FDA, interacting with FDA officials with or without management; will be a DRA representative on assigned international project teams, and obtain input from regulatory associates in key regions and affiliated companies; responsible for evaluating regulations, establishing framework, designing and implementing science based registration strategies for assigned compounds to ensure rapid global registration consistent with TPP. Duties include review of key documentation to assess the appropriateness of all submissions and/or major document to health authorities. The incumbent will coordinate all meetings with the FDA and will play a important role in review /clearance of promotional materials. Position and specificity of has flexibility to accommodate individuals with varying background. Sr-level role may have staff management responsibility. (The junior-level person would work through a senior level DRA professional, who would be the point person)

Minimum requirements Strong knowledge of US regulatory affairs and FDA regulations; Hands-on EU experience with registration and legislation a plus; Good understanding of the drug development process a must; Candidates must possess a MS; PhD or PharmD preferred. Need relevant experience in regulatory affairs; Knowledge of Japan, Asian or other regulatory bodies preferred; Strong computer, organizational, interpersonal, oral and written communication skills are mandatory; Experience and skills to modulate the external environment to support regulatory objectives is desirable, as is knowledge of challenges in international drug development. ** Level of the incumbent will be based on experience and knowledge of regulatory affairs, drug development or equivalent; accountabilities/duties assigned commensurately **

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