Director, Regulatory Affairs The Director of Regulatory Affairs for our San Diego based client, whose focus is in the respiratory and drug delivery area, will have the responsibility of communicating with government agencies regarding investigational products, interpretation of regulations and setting strategies for the submission of all documents to federal agencies. The ideal candidate will have: Bachelor of Science and eight to ten years pharmaceutical regulatory experience or equivalent. Thorough understanding of 21 CFR and regulatory guidelines. Aerosol and/or Inhalation experience. Extensive experience in the preparation of CMC sections is required. Exposure to the FDA and worldwide regulatory bodies is required. Must be experienced as a manager, mentor and effective leader with a proven track record of outstanding results. [ back ]
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