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regulatory affairs in Boston

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  1. Head, Drug Product Process Development at Moderna Therapeutics, Inc

    Interact with other R&D groups (clinical/PK/PD/Tox) to advance the science of RNA pharmaceutics. Experience formulating nucleic acids for in vivo delivery,...

  2. Audit Senior Associate at Edelstein & Company LLP

    Experience in startups, manufacturing, technology, biotech, and professional service industry a plus. Supervise, train, and mentor associates and interns on...

  3. Research Associate at NantKwest

    BS in biological sciences and a minimum of 2-5 years related academic and/or industry experience, or MS with at least 1 year of work experience preferably in...

  4. Director/Sr. Director, CMC Regulatory Affairs at Sage Therapeutics

    Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred....

  5. Program Manager (Pharma or Biotech) at Solid GT

    Pharma and Biotech PROGRAM MANAGER. Understanding of the regulatory process for a new drug application and organization of data for regulatory interaction....

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    1. Regulatory Affairs Specialist

      The Sr. Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising, mentoring and guiding the local organization on regulatory topics. They are also responsible for providing regulatory support to product development teams to insure ...

    1. Head of Global Sales - (Market Research Software) at Eli Global

      Pharma Database is a decision making tool (workflow tool) to be used by decision makers in Pharma and Biotech companies....

    1. Compliance Engineer - Clinical Chemistry Instruments & Reagents

      Seeking experienced Compliance Specialist with a background in a medical device or diagnostics product company to join a major manufacturer of Clinical Chemistry Instruments and Reagents as a part of the Regulatory and Quality team working to eliminate compliance risks, reduce adverse events, and improve risk mitigation efforts. About: *** Requires experience in a Quality and Regulatory ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Medical Science Liaison OR Associate Director, MSL- Oncology - New England at Boehringer Ingelheim

      Compliance and other regulatory and/or organizational requirements:. Advanced science / clinical degree (PharmD, M.D., DO, Ph.D.)....

    1. Quality & Regulatory Affairs Specialist - Diagnostic Testing Products

      Seeking individual with experience within a medical device, pharmaceutical, or diagnostic testing product manufacturer to join a growing company located in the heart of the Number 1 ranked Biopharma Cluster in the US. Must be able to: *** Assess the existing quality system and implement improvements to reduce or eliminate regulatory compliance risks. *** Conduct internal audits and ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Medical Science Liaison / Senior Medical Liaison (LA, MS, AL, GA, TN) at Takeda Pharmaceuticals

      And provide clinical/scientific support for Takeda Oncology and Medical Affairs department initiatives at the direction of Medical Affairs management....

    1. Medical Device Compliance Specialist - Post Market Surveillance

      Exciting opportunity to join a rapidly growing company located in the biggest biotech hub in the country! This is a fantastic growth opportunity within a financially strong company with a diverse product line of advanced laboratory instrumentation, test devices, and associated reagents, enzymes, lab supplies, titrations, etc. Requirements: *** Experience within a quality compliance, ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Principal or Senior Mechanical Engineer at NeuroLogica

      R & D – Mechanical Engineering. Comply with regulatory and quality requirements for medical devices. Are you sick and tired of design work that has limited...

    1. Sr. Risk Management Specialist

      Job Description:This position will lead risk management related activities for existing devices and support post-market quality by assisting with analysis and investigation of product or quality system issues and carrying out continuous improvement efforts. Primary responsibilities for this position include risk assessment, maintenance, and management as documented within the risk management ...

    1. Alliance Manager at NantKwest

      3-5 years in the Biotech or Pharmaceutical industry is a must. NantKwest is seeking an Alliance Manager to provide administrative and project support to the EVP...

    1. Senior Manager Regulatory Affairs (Oncology)

      Responsibilities:Life-cycle management of the regulatory submission process from initiation to approval.Involved in managing and preparing all regulatory documentations at different Regulatory milestones.Liaison to Regulatory Project Management to help develop submission content plans.Assisting in the development and evaluation of regulatory strategies for projects.High level of communication ...

    1. Metrology and Validation Services Lead at Toxikon Corporation

      Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device, and Biotech industries....

    1. Senior Medical Director, Medical Affairs- Hematology/Oncology

      Position Title: (Senior) Medical Director, Medical Affairs Hematology/OncologyExciting opportunity to join a rapidly growing company in the Boston area! Candidates must have strong Medical Affairs experience in Hem/Onc with an MD degree to be considered.Position Summary:Reporting directly to the Vice President of Global Medical Affairs, the (Sr) Medical Director will provide overall strategic ...

    1. Study Director, Ocular Services at Toxikon Corporation

      Our mission continues to focus on providing quality pre-clinical services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device...

    1. Expert Product Registration / Product Steward 191.16CM

      :: 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 Product Steward will be responsible for proactively advising business managers and research & technology project manager on product registration and product stewardship activities. Qualifications: -BS/MS in science or chemistry ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Lead In-Market HR Partner (JAX) at Lead In-Market HR Partner (JAX)

      SPHR o r GPH R certification preferred. Plan s an d executes HR strategy. M as te r' s Degree in Human Resources, Psychology and/or Business preferred....

    1. Director of Regulatory Affairs

      Director of Regulatory AffairsIndustry Leader in Pharmaceutical ManufacturingCOMPENSATIONFull Benefits with Bonus EligibleRelocation Assistance AvailableDESCRIPTIONThe Director of Regulatory Affairs will spot, analyze and foresee any regulatory issues and formulate and execute regulatory plans and direction.RESPONSIBILITIESGather and produce information for regulatory submissions to ...

    1. Senior Transparency Reporting Platform Specialist at Shire Pharmaceuticals

      Job Description: Primary Role The Senior Transparency Reporting Platform Specialist will assume primary business support for Shire’s US based transparency

    1. Regulatory Specialist - Medical Device

      The Medical device Regulatory Specialist will provide direct regulatory support to various projects and products, both new and existing. Responsibilities may include:Preparing regulatory registration, notification, and pre-market submission requirements, including the necessary regulatory documents.Providing regulatory support for product changes/modifications, labeling, and promotional ...

    1. MDM Consultant/Data Analyst at Eliassen Group

      Our consulting divisions include expertise focused on Agile, Big Data, Biometrics & Data Solutions, Creative Services, Government Services, Life Sciences and...

    1. Medical Science Liaison - Ophthalmology (New England)

      Novartis is recruiting for a Medical Science Liaison (MSL) to cover the New England US Region. Preferred area of residence is within the area of coverage: Boston, MA; Upstate NY.A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. This pipeline consists of innovative medicines brought to life by diverse, talented, performance driven people ...

    2. Statistician - Pharmaceuticals - cGMP & Trials - Lawrence, MA

      Seeking individual with extensive statistical modeling and analysis experience for the pharmaceutical industry to contribute to regulatory filings, research interpretation, long-term decisions, and critical strategy development. *** Work directly with scientists and managers in Clinical Research, Manufacturing, and Medical Affairs to advise on the best ways to collect, manage, analyze, and ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    3. Senior Project Manager, Clinical Affairs

       This position has the responsibility and authority to be a significant contributor to the overall clinical development strategy for products/therapies within the surgical business. Managing all aspects of clinical strategies, study design and development, study execution, monitoring, and addressing issues during clinical trials. Manage data analysis and clinical trial report writing, and ...

    4. Senior Medical Writer (Clinical)

      Job Description: As a Senior Medical Writer, you lead medical writing initiatives within R&D across various therapeutic areas, collaborating with both local and global cross-functional teams for Phase 1-4 clinical studies, including IND and NDA sections.Key Job Responsibilities:Direct and lead the writing, reviewing, editing and approval of clinical documentsAuthor documents while ...

    5. DATA ANALYTICS LEAD

      Immediate Opportunity – DATA ANALYTICS LEAD My name is Donald Barnable and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a DATA ANALYTICS LEAD for a prominent client of ours.  This position is located in CAMBRIDGE, MA. Details for the position are as follows: Job   Description:Seeking a top-notch DATA ANALYTICS LEADThe Data and Analytics Lead (DAL) ...

    6. Data & Analytics Lead (Biometrics)

      Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis. Title: Data and Analytics LeadJob ID: 8175Industry: Biotech/PharmaceuticalLocation: Cambridge, MAType: ContractPay Rate Range: Depends on Experience (W2, no benefits attached) Job ...

    7. Project Manager, Senior, Clinical Affairs

       This position has the responsibility and authority to be a significant contributor to the overall clinical development strategy for products/therapies within the surgical business. Managing all aspects of clinical strategies, study design and development, study execution, monitoring, and addressing issues during clinical trials. Manage data analysis and clinical trial report writing, and ...

    8. Senior Clinical Project Manager

      SUMMARY:The Senior Clinical Project Manager (SPM) is responsible for overall management of all phases of clinical trials, from start-up through completion of activities, utilizing Company or sponsor Standard Operating Procedures (as applicable), FDA regulations, and ICH-GCP guidelines. In-depth knowledge and experience of the drug development process is required, including study initiation, ...

    9. New Position Available! - Regulatory Affairs Specialist - Pharma/Biot

      How are you,This is John Liotine, I represent The Fountain Group a national staffing firm.  I am currently reaching out to you to fill a position as a Regulatory Affairs Specialist for a prominent Medical Device Corporation of ours.  This position is located in Cincinnati, OH.Details for the positions are as follows: WE ARE LOOKING FOR SOMEONE TO RELOCATE TO CINCINNATI, ONSITE INTERVIEW ...

      1. Director of Sales at JoVE

        JoVE (www.jove.com ) provides first-of-its-kind online video-based journals and databases to universities and colleges with the mission to increase

      2. Sales Account Manager at JoVE

        We are looking for a driven, ambitious B2B Sales Account Manager with experience in higher education, publishing, technology and/or pharmaceuticals sales...

      3. Associate Director, CMC Regulatory Affairs at Sage Therapeutics

        Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred....

      4. Senior Manager/Manager, Clinical Operations and Development at Sage Therapeutics

        Oversee clinical development programs (pre-IND through Phase 1-3 clinical trials) in the field of neurology and CNS disorders. This key role will manage, plan

      5. Study Director, Efficacy and Surgical Research Services at Toxikon Corporation

        Assist/manage technical site visits of the department related to assigned projects and assisting Quality Assurance and Regulatory Affairs with all vendor...