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  1. 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...

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

    8-10 years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC)...

  3. Associate Director, CMC Regulatory Affairs at Sage Therapeutics

    5+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC)...

  4. Director, Regulatory Operations and Compliance - Vaccine Business Unit at Takeda Pharmaceuticals

    Manages QMS Continuous Improvement and Monitoring effort from Regulatory Affairs Vaccines perspective, including activities such as procedure authoring, review,...

  5. Senior Manager, Public Relations at PixarBio Corporation

    Coordinates Legal, Medical and Regulatory internal review process for materials developed. Potential litigation, product discontinuation and supply issues and...

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    1. Manager, Regulatory Affairs

      Regulatory Affairs Manager   The Manager of Regulatory Affairs reports to the Senior Director, Regulatory Affairs. Responsibilities include managing and supporting a variety of regulatory projects, including:  Determining effective regulatory pathways for a variety of products types Participate in cross-functional teams to implement the regulatory strategies for the timely support of project ...

    1. Medical Science Liaison/AD, Medical Science Liaison - CV/Met (Upstate NY, CT, VT) at Boehringer Ingelheim

      Compliance and other regulatory. Additional scientific support for Medicine and Scientific Affairs. Leading field based medicine or medical affairs projects, or...

    1. Manager of CMC Regulatory Affairs - 1650037359

      The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and ...

    1. Regulatory Affairs Operations Officer at Harvard University

      Reporting to the Associate Director of Regulatory Affairs Operations, the Regulatory Affairs Operations Officer works to build consensus and partnerships as...

    1. Manager of CMC Regulatory Affairs - 1650037359

      The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and ...

    1. Regulatory Affairs Officer at Santander Bank

      Implement standards and procedures to support the Regulatory Affairs function. Provide direct support for the Regulatory Affairs Directors current...

    1. Director of Regulatory Affairs - Clinical Trials - Boston, MA

      Seeking clinical trial experience to: *** Provide regulatory leadership and develop regulatory strategies for products in development to achieve clearances and approvals in the US and internationally. *** Manage regulatory risk. *** Plan, prepare, and review submissions to regulatory authorities to support the conduct of clinical trials, including but not limited to Investigational New ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Chief Medical Officer, Valera at Moderna Therapeutics, Inc

      Pharmacology, Statistics, Regulatory Affairs, Clinical Operations, etc. Biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)....

    1. Regulatory Affairs Specialist-12049

      Contract opportunity in Mansfield MA through 11-11-2017**Must be able to be a direct W2 of Three Point Solutions, Inc.JOB TITLE: Regulatory Affairs Specialist-12049This is probably more aligned with a Supplier Quality Engineering role. Job Description:Regulatory Affairs Specialist will serve as a regulatory team member to support a variety of activities in association with the implementation ...

    1. Lead HR Business Partner, R&D (Director) at Shire

      Supporting global organizations including Global Regulatory Affairs and Global Drug Safety. Experience in the pharmaceutical industry preferred, with prior...

    1. Regulatory Affairs Specialist

      Job Description:Work Hours - 9-5PM Position Summary Coordinate activities for a variety of device regulatory approvals in association with Client rebranding including: database management, labeling reviews, export certificates and technical documentation.Responsibilities: Label reviewObtain regulatory information from various sources to maintain product information databasesOrganizes ...

    1. VP/SVP Global Regulatory Affairs at Celldex Therapeutics, Inc.

      VP/SVP Global Regulatory Affairs*. Regulatory drug development:. The regulatory lead will oversee both the strategic and operational aspects of the regulatory...

    1. Regulatory Affairs Manager

      Key Responsibilities:• Publishes and/or manages publishing regulatory submission documents such as INDs, NDAs and IMPDs• Manages electronic submission activities to meet the company's targeted submission timeline• Supports to establish an internal electronic submission system and relevant procedures• Communicates with the e-submission vendor as necessary for an efficient and accurate ...

    1. Thought Leader Liaison - Dermatology (Boston, MA) at Regeneron

      Work within label, and regulatory and legal compliance guidelines. A TLL will work cross-functionally with home-office based colleagues in Marketing, Medical...

    1. Regulatory Affairs Specialist 11651

      Contract opportunity with our client through 1/27/2017**Must be able to be a direct W2 of Three Point Solutions, Inc.**Bachelors degree requiredDescription:The 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 ...

    1. Principal Regulatory Operations Associate at Alnylam

      Collaborate with Regulatory Affairs staff and. Principal Regulatory Operations. Provide advice on regulatory. That meet global regulatory requirements....

    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. Regulatory Affairs Leader at Fairway Consulting Group

      Regulatory Affairs Certification (RAPS). Files/Maintains regulatory deliverables. They have asked us to assist them in their search for a Regulatory Affairs...

    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. Professional Education Manager, DePuy Synthes Institute: North Central at DePuy Synthes Sales, Inc.

      Advamed, Pharma, ACCME and other global legal and regulatory bodies. They must ensure compliance to all legal, regulatory and HCC policies to include;...

    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 ...

    2. Regulatory Affairs Specialist

      I have a client in Mansfield looking for a backfill for a full-time employee on temporary leave.  This contract will run until January 31st, 2017.  I need someone who can step in with very little training needed.  Medical device regulatory experience is required.  Rate will be around $75/hr. w2.  Corp to corp is also available.Description:Provide regulatory assessments of manufacturing, ...

      1. Registered Nurse - Quality Improvement at All Care Resource

        Knowledge of Certified Home Health Agency regulatory affairs and Medicare Conditions of Participation. All Care Visiting Nurse Association has a full-time...

      2. HOTEL OPERATIONS SUPERVISOR at Ameristar Casino Hotel

        Maintains an appropriate level of community affairs involvement. Adheres to, interpret, support, and explain established company policies and procedures as well...

      3. Commercial Loan Officer at East Boston Savings Bank

        Monitor credit files and borrower activity to ensure that complex credit files are reviewed annually for compliance with current financial information, risk...

      4. ALPFA - Business Partner Groups at BNY Mellon

        Overall responsibility for government affairs and advises on advocacy and. Legal department mitigates risk and handles legal affairs to ensure the....

      5. 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...