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regulatory affairs in Raleigh

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    1. Assistant Preschool Teacher

      Construction Kids Weekday Preschool seeks to hire Assistant Teachers for its Mother's Day Out program. Openings - 1 year olds - 3 days/week (Tuesday-Thursday) Responsibilities A. Assist Lead Teacher in planning and implementing activities, incorporating approved curriculum to meet the spiritual, physical, emotional, intellectual and social needs of the children B. Ensure children are supervised at all times C. Assist Lead Teacher in communicating with parents and members of the community D. Assist Lead Teacher in maintaining schedule and classroom expectations. E. Perform other ...

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    1. Drug Safety Associate at Global Pharma Tek, LLC

      Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data...

    2. Director - Program Management at Merz North America, Inc.

      Research, Clinical, Biostatistics, Tech Ops, QA, Regulatory Affairs, Medical, and Commercial) to ensure that programs have fully integrated development plans to...

    3. Clinical Project Director / Senior PM, (CRO/Chapel Hill) - Direct Hire at Frankel Staffing Partners

      The select candidate will be charged with the successful integration of all clinical trial activities, acting as the primary liaison with the trial Sponsor and...

    4. Regulatory Affairs Administrator at Chiltern

      To report directly to the Regulatory Affairs Officer, Senior Regulatory Affairs Officer, Manager Regulatory Affairs, Associate Director Regulatory Affairs and...

    5. Senior Director Regulatory Affairs at Merz North America, Inc.

      At least 10 years of increasing US Regulatory Affairs experience is required. Provide regulatory strategy, due diligence, regulatory scientific review of health...

    1. Healthcare Compliance-Health Insurance

      Healthcare Compliance Consultant (Medicare)-Durham NC 1317 49.66-52.97 W2 contract 3 months+ Responsible for leading day-to-day activities required to maintain an effective compliance program, including the coordination of highly complex, cross functional matters related to organizational compliance. Identifies compliance risks, develops and/or facilitates implementation of corrective ...

    2. Director - Regulatory Affairs - OPDP Liaison

      Responsible for regulatory review, approval, and submission of all US Promotional materials to the FDA Office of Prescription Drug Promotion (OPDP). Shall: *** Manage changes to US labeling and collaboration with partners on labeling and responses supporting initial registration and communications regarding any changes to US labeling. *** Provide strategic and operational leadership ...

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    3. Chemist II Tech. Support

      Job Description: The TSS Chemist II is responsible for the evaluation, development and validation of methods required for raw materials and finished products. Performs qualitative and quantitative analyses of organic and inorganic compounds to determine the identity, purity and homogeneity of drug substances and products related to each project. Assists in conducting research to develop ...

    4. Associate Director, Regulatory Affairs (Clinical Development)

      Job Description: Job Purpose:Manages all regulatory interactions with local health authorities and development of regional RA strategiesMajor Accountabilities:• Central contact point for all Novartis Vaccines regulatory interactions with the respective local Health Authorities • Monitors local guidelines and vaccine specific recommendations • Prepares and/or comments on draft documentation ...

    5. Study Start up Associate (Permanent) - 1510162

      Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained in ISSC are in compliance with International Congress on Harmonization ...

    6. Pharmacovigilance Compliance Manager

      Job Description: Job Purpose:Provides support to the PV department leading the following activities: -Support to BRPs and EUQPPV in the management, coordination, development, reviewing, and tracking of risk management plans - Compliance role, i.e. ensuring timely review and storage of minutes from PV committees (SMT, PSB), tracking of PV CAPAs, SOPs change requests - Operational coordinator i ...

    7. Medical Director - Medical Affairs - Reproductive Endocrinology

      Lead North American Medical Affairs team during new product launches for therapeutic solutions to reproductive health issues. Shall: *** Create scientifically and medically accurate educational materials for internal and external stakeholders. *** Develop comprehensive strategic and operational plans for medical affairs new product launch team. *** Oversee submittal of safety ...

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    8. Site Quality Manager

       POSITION TITLE:              Site Quality Manager (Raleigh)                        DEPARTMENT:  Quality Operations                              BUSINESS UNIT:               Pharmaceuticals                  REPORTS TO:     Vice-President, Quality Operations                  SUMMARY OF POSITION:  Manages all Quality functions for the site, including: quality control, quality assurance, ...