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regulatory affairs in Chicago

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  1. Packaging Consultant

       Business Sector: Scientific  Job Title: Packaging Consultant  High Level Job Description:Packaging development activities for channels customization projects, including:  - Sizing for new wrappers, bags, cartons, bottles, corrugated cases or displays.  - Identifying material specifications for new packages.  - Work with suppliers to create new drawings and samples.  - Performance testing in packaging R&D lab.  - On-site testing at various plants and co-packer sites.  - Development of pallet ...

  2. Product Manager - New Drug Launch - Relocation to RTP, NC

    Precept Life Sciencs is hiring a Product Manager to work with our pharmaceutical client in Research Triangle Park, NC. The ideal candidate will manage the product launch of a new respiratory drug. **Relocation assistance available**   Major Accountabilities / Responsibilities: Assist in the development of brand strategy, tactical plans, and budget. Gather and analyze insights from inside and outside of the organization. Participate in the creation of annual brand plans and tactical plans. ...

  3. ASSOCIATE DIRECTOR REGULATORY AFFAIRS

    Our client is currently seeking a ASSOCIATE DIRECTOR PRODUCT REGULATORY AFFAIRS. Bachelor Degree minimum requirement, Master Degree, PhD, or RPh strongly preferred. Must have at least ten years of experience in the pharmaceutical industry or relevant medical device experience as needed for the position. Must have experience working directly with regulatory agencies. Sound knowledge of applicable portions of global regulatory guidance and regulations. Must have had strong communications with the FDA ...

  4. Senior Clinical Research Associate

    We are looking for a Midwest CRA with Oncology and Infectious disease.  Must have both therapeutic areas to be considered.   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ...

  5. Senior Clinical Research Associate

    We are looking for a Midwest CRA with Oncology and Infectious disease.  Must have both therapeutic areas to be considered.   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ...

  6. Pharmacometrics - Director Model Based Drug Development - Chicago, IL

    Shall work closely with candidate drug selection team and support preclinical and ealy clinical phases of small and large molecule drug development and lead Model Based Drug Development planning and implementation. Must have experience in Model Based Drug Development and independently developing pharmaco-statistical models including disease, exposure response, biomarker, efficacy, etc. in collaboration with physicians, DMPK PK-PD scientists, statisticians, clinical pharmacologists and regulatory ...

  7. Director Regulatory Affairs, Area & Affilate US/Canada  HH

    Director Regulatory Affairs, Area & Affiliate US/Canada- Chicago PRIMARY JOB FUNCTION: Candidate will be responsible for contributing to and implementing strategies to support assigned projects within Therapeutic Area (e.g., HCV). CORE JOB RESPONSIBILITIES: • Review, compile, and submit variations, new applications, supplements and amendments, as well as responses to Health Authorities as needed • Development, defense, and implementation of robust Regulatory Strategy and Tactical plan for ...

  8. Senior Director hh

    Senior Director, Regulatory Affairs, Area & Affiliates US & Canada Description Primary Job Function: The function of a Senior Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has division and corporate level influence and is generally considered a key opinion ...

  9. 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 ...