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regulatory affairs in Baltimore

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    1. Medical Affairs Specialist

      The Medical Scientist will be a renowned expert in own field and may specialize in more than one area. This individual will work independently with guidance in only the most complex situations and serve as a close partner to the physician on the team. S/he may coordinate the activity of a research team and will hold full accountability for projects, often with Global impact. This position ...

    2. Regulatory Affairs Manager (REMOTE)

       Description- Prepare and deliver regulatory operational plans for allocated projects/products. Contribute to solutions to regulatory issues. Project manage quality regulatory submissions to agreed project targets. Provide operational regulatory input and guidance in cross-functional teams. Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the ...

    3. Infectious Disease - Phase II-III Clinical Trials - Medical Lead

      Seeking record of success in developing, planning, designing and executing clinical studies in active pursuit of new therapeutic registration. Qualifications: *** M.D. or D.O. with extensive knowledge of designing clinical studies for infectious disease therapeutics. *** Strong experience supporting submissions to the FDA and other regulatory groups. *** Proven track record in new ...

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    4. Regulatory Affairs Manager

      A leading pharmaceutical company in Gaithersburg, MD has an immediate need for an onsite or remote based Regulatory Affairs Manager. The Regulatory Affairs Manager will prepare and deliver regulatory operational plans for allocated projects/products. Contribute to solutions to regulatory issues. Project manage quality regulatory submissions to agreed project targets. Provide operational ...