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regulatory affairs in Chicago

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  1. Regulatory Affairs Specialist 357.14CM

    :: If you meet the qualifications listed below and would like more information contact Crystal at 815-756-1221. Attach resume when responding to this posting :: The Specialist will be responsible for tracking global and country-level agricultural, emulsion polymerization, and polyol chemical product registration requirements including US, EPA, FDA, and Canada PMRA regulations. Qualifications: -BS in chemistry, toxicology, or related; MS preferred -Solid knowledge of US regulations and standards ...

  2. Medical Reviewer/Safety Reviewer

    Minimum Requirements: *Candidates must be a minimum of a BSN. *Working knowledge of Excel and PowerPoint. *CRO or Pharmaceutical experience, preferred not required. Coding important - WHO-DRUG, MedDRA, and Pharma Please note candidates experience working with Excel and PowerPoint.   Job Description: Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. Assist in managing the ...

  3. Validation Engineer

      Validation Scientist / Engineer II   Position Purpose: Designs, schedules, and executes scientifically and statistically sound qualification/validation experiments which demonstrate that manufacturing Equipment, Facilities, Utilities, Systems, and Processes are in compliance with regulatory requirements, product license restrictions, and industry guidance. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. ...

  4. Medical Officer

    ~~RESPONSIBILITIES 1. Project Assignments • Medical Officer is qualified to exercise the responsibilities of a medical monitor, safety officer, or protocol physician in projects where medical monitoring is a contract deliverable 2. Medical Affairs • Primary or secondary contact for the customer and the sponsor (if not the same entity) for all project-specific medical issues • Primary contact for the project team for all project-specific medical issues • Primary contact for investigative sites for ...

  5. Medical Advisor (Nationwide)

    Our client is seeking a Medical Advisor II that will provide medical and scientific support to both internal team members and external healthcare decision makers and respond to information inquiries. The Medical Advisor will provide scientific support to the commercial activities, research, marketing, and report safety issues within the region consistent with legal and regulatory requirements.   Responsibilities: •Develop and manage relationship with Thought Leaders through scientific exchange ...

  6. Sr. Director, Regulatory & Quality

    A biopharmaceutical company is actively seeking a Sr. Director, Regulatory & Quality to join their team. This is a full-time permanent position and must be office-based in Chicago, IL.  Candidates must possess the following experience:  Experience with Drug, Pharma, Device, Quality, US, Global experience (ideal candidate will have all of this) Drug experience is absolutely required 8+ years of increasingly responsible regulatory experience  Deep and broad knowledge of regulatory affairs ...

  7. Quality Systems Technical Writer

    Motivated, savvy quality systems technical writer with extensive experience writing/updating business process documentation, standard operating procedures (SOP), and work instructions.  Can serve as an active voice for quality systems in project meetings as well as cultivate on-going, relationship with the business, quality and IT communities.  Open communicator with a collaborative, proactive approach to problem-solving and issue resolution.  Self-starter with proven leadership ability to utilize ...

  8. Director Regulatory Affairs CMC hh

    Director, Regulatory Affairs CMC Chicago Description Primary Function • Lead a team of global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers • Key internal leader and driver of regulatory policy and strategy • Influence the development of regulations and guidance • Provide executive management with meaningful regulatory measurements and regulatory opinion • Partner with outside regulatory agencies and trade ...