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  1. Manager - Regulatory Affairs at Cardinal Health

    The Regulatory Affairs Manager is responsible for:. Participates on project teams representing Regulatory Affairs to provide inputs and answer questions related...

  2. Advisor - Regulatory Affairs at Cardinal Health

    Advanced degree and/or regulatory affairs certification (RAC) preferred. Represent regulatory function on project teams and provide input on regulatory strategy...

  3. Senior Clinical Trial Manager at Global Blood Therapeutics, Inc. (GBT)

    In close collaboration with the VP Clinical Operations & Regulatory Affairs, the Sr. Liaise with other functional areas (preclinical development, pharmaceutical...

  4. Field MSL Director, Oncology (West) at Astellas Pharmaceuticals

    Accomplishes goals within boundaries established by regulatory and legal compliance in accordance with company policies and sound ethical practices....

  5. Clinical Research Specialist (Clinical Site Manager) at Medtronic

    This position will work closely with all levels of the Clinical Affairs department as well as other departments including Clinical Operations, Marketing,...

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    1. Regulatory Affairs Specialist (Complaint Handling)

      Hello, My name is Chrys and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is located in Mountain View, CA Details for the position are as follows: Job Description:Effectively implements the complaint handling process and processes complaints in a uniform and timely ...

    1. Regional Director, Sales – HVT West Region at Edwards Lifesciences

      Collaborates with functional departments of the company, specifically but not limited to Operations, Finance, Marketing, Human Resources, R&D, Regulatory...

    1. Regulatory Affairs Director / Clinical Design Manager  Clinical Trials

      Too frequently, physicians exhaust all available treatment options for cancer patients. However, every cancer tumor contains unique genomic changes that can be targeted to attack the tumor. Our Client had developed sequencing which unlocks the genomic information physicians need to optimize treatment providing DNA-based cancer testing technology. The Regulatory Affairs professional will be ...

    1. Oncology Medical Science Liaison/Sr. MSL - Women's Cancer I/O- CO/UT/NV/WY at AstraZeneca

      Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...

    1. 2 Regulatory Affairs Associate-PMA Annual reports-

      Regulatory Affairs Associate –SANTA CLARA CA59585 40-45.00 AN HOUR W2 CONTRACT 6 MONTHS+Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of ...

    1. Diabetes Medical Science Liaison/Sr MSL - Upstate NY/Vermont at AstraZeneca

      Identify pre-clinical, clinical and post-marketing study investigators in alignment with Medical Affairs objectives....

    1. Regulatory Affairs - All Levels

      Top 3 Skills: · 1+ years of experience in regulatory affairs, or biotech industry· Manufacture, testing (QC/QA or clinical), or distribution in Biotech/Pharma industry· Excellent communication (both written and verbal), presentation and facilitation skillJob Description:Support Chemistry Manufacturing and Control Regulatory staff performing product development and lifecycle management. ...

    1. Diabetes Clinical Science Liaison - Upstate NY/VT at AstraZeneca

      Medical Affairs Team Members. Adhere to internal standard processes and comply with regulatory and compliance requirements....

    1. Regulatory Affairs Specialist

      This is an this exciting role with a leading and successful food manufacturer based out of the San Francisco Bay area. As their Regulatory Affairs Specialist, not only will you be part of an amazing team of professionals but you will also be  in charge of recommending and implementing regulatory compliance strategies to support business, while working closely with the R&D, Production and ...

    1. Manager, Field Clinical Analytics at St. Jude Medical

      We are seeking an experienced, high caliber Field Clinical Affairs Manager, Clinical Analytics. The Field Clinical Affairs, Manager, Clinical Analytics, will...

    1. Manager - Quality Assurance and Regulatory Affairs

      NeilMed Pharmaceuticals, Inc. is an ISO certified manufacturer of Class I medical devices. Our products are registered with the FDA and manufactured at our Corporate Headquarters in Santa Rosa, California.  Due to expansion, we are looking for an additional Quality Assurance & Regulatory Affairs Manager to add to our quality team. The position is responsible for the development and ...

    1. PROS- Project Leader at PAREXEL International

      PAREXEL currently has an excellent opportunity for a Project Leader/Project Manager with previous experience in Regulatory Operations and/or Regulatory Affairs....

    1. Regulatory Affairs Associate (439033)

      OVERVIEW: Reporting to the Manager/Senior Manager, Regulatory Affairs, Chemistry Manufacturing and Controls (CMC), you’ll be responsible for:Coordinating the planning, preparation and submission of global regulatory CMC-related submissions, including post approval variations, Marketing Application(s) and Annual ReportsDeveloping and/or reviewing regulatory documents to ensure that all ...

    1. Director, Regulatory Affairs at Quintiles Transnational

      Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs business plans....

    1. Regulatory Affairs CMC Associate (439033)

      OVERVIEW:Reporting to the Manager/Senior Manager, Regulatory Affairs, CMC, you’ll be responsible for:- Coordinating the planning, preparation and submission of global regulatory CMC-related submissions, including post approval variations, Marketing Application(s) and Annual Reports- Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet ...

    1. Oncology Medical Science Liaison - Women's Cancer I/O - NY State/CT/RI at AstraZeneca

      Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...

    1. Regulatory Affairs Associate II / Senior (439032)

      OVERVIEW:The Associate, Regulatory Affairs will be assisting the regulatory team in supporting clinical and/or nonclinical studies.RESPONSIBILITIES:Coordinate the preparation and submission of domestic and international regulatory submissions related to clinical and nonclinical aspects of product development, including the following:•   INDs or international equivalents and amendments•   NDAs ...

    1. Director, Regulatory Affairs-CMC at Valeant

      The Regulatory Affairs – CMC Director independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals products throughout their lifecycle....

    1. Regulatory Affairs Associate (439031)

      OVERVIEW:The Associate, Regulatory Affairs will be assisting the regulatory team in supporting clinical and/or nonclinical studies.RESPONSIBILITIES:Coordinate the preparation and submission of domestic and international regulatory submissions related to clinical and nonclinical aspects of 0product development, including the following:   o INDs or international equivalents and amendments   o ...

    1. Director, Regulatory Affairs-CMC at Dow Pharmaceutical Sciences

      The Regulatory Affairs – CMC Director independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals products throughout their lifecycle....

      1. STATISTICIAN - CANCER CENTER WHELAN RESEARCH - MSW at Mount Sinai Health System

        Regulatory affairs of the IRB. Meets regulatory, licensure and annual health. Mount Sinai Health System Careers....

      2. Director, Health Economics and Outcomes Research at Management Recruiters of the Rockies

        Management develop and define a health economics plan, with precise value messaging and strategies to support these tactics Provide input to clinical and...

      3. Senior Clinical Research Operations Specialist at Chiltern International

        Interface with Regulatory Affairs to obtain regulatory document approval for clinical study sites; Coordinate site regulatory document collection for assigned...

      4. Medical Communications Leader at A New Beginning - Genesis 2

        Has a firm understanding of legal/regulatory topics sufficient to describe the basis of Medical Affairs policies and procedures, and applies this knowledge to...

      5. Patent Attorney at Global Blood Therapeutics

        Experience in drug regulatory affairs is a plus. In addition to working with R&D to monitor the progress of research programs, evaluate freedom to operate and...