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  1. 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)...

  2. 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)...

  3. Associate Director / Director, Pharmacovigilance at Sarepta Therapeutics

    Collaborate with PV vendors and Regulatory Affairs to ensure appropriate reporting of PV and drug safety information to regulatory agencies and prescriber...

  4. Senior Regulatory Affairs Specialist, Relocate to Auckland, New Zealand at Fisher & Paykel Healthcare

    As a Senior Regulatory Affairs Specialist at Fisher & Paykel Healthcare you will obtain and maintain market access for our cutting edge products worldwide by...

  5. 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,...

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    1. Product Manager (0063)

      About the Opportunity A Massachusetts-based pharmaceutical company is currently seeking an experienced Product Manager for a promising position with their growing staff. Reporting to the Director of Solid Tumor Marketing, the Product Manager will be responsible for working closely with the Field Sales, Sales Training, Medical Affairs, Legal, and Regulatory teams to develop, execute and ...

    1. Senior Clinical Scientist at Seqirus, A CSL Company

      Liaisons with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) and investigators....

    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. IHP Assistant/Associate Professor/NP- VANAP-GE Program, School of Nursing (FACULTY) at Massachusetts General Hospital(MGH)

      The selected candidate will be based primarily at the Veterans Affairs Medical Center in White River Junction, VT, but will need to travel to Charlestown, MA...

    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 Specialist at Eliassen Group

      The primary task for this Regulatory Affairs Specialist is to provide significant regulatory support for the defibrillator PMA submissions to FDA....

    1. Director of Regulatory & Regulatory Strategy (440773)

      OVERVIEW:Determines and develops the global regulatory strategy and objectives for interactions with FDA and other governing bodies.Accountable for preparation and filing of briefing books, including coordination and planning for pre-Submission meetings with FDA.Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management ...

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

      Compliance and other regulatory and/or organizational requirements:. Experience leading field based medicine or medical affairs projects, or mentoring MSLs –...

    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 ...

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      No Telecommute

    1. Research Administrator I - The Fletcher School at TUFTS University

      Understanding of regulations that govern federal research funding and related areas of regulatory compliance....

    1. Clinical Research Associate

      Sharf Woodward & Associates Clinical Research Associate  LOCATION: Boston MA (Contract) 18-24 months POSITION SUMMARY: Responsible for site management and performance (including documentation) of on-site monitoring (all types of visits) activities for multiple investigational sites in accordance with designated project assignments, (SOPs), Good Clinical Practices (GCPs) and applicable ...

    1. Regulatory Affairs Assistant at Sales Consultants of Morris County

      REGULATORY AFFAIRS ASSISTANT Under the supervision of the Regulatory Affairs & Scientific Support Manager, the employee is primarily responsible for the...

    1. CMC Manager

       Hello, My name is Carlane and I represent The Fountain Group. We are a national staffing firm and are currently seeking a CMC Manager position  for a prominent client of ours.  This position is located in Allston, MA Details for he position are as follows: Job DescriptionPerform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document ...

    1. Coordinator, Medical Affairs Operations (Palo Alto, CA or Philadelphia, PA) at Jazz Pharmaceuticals

      The Medical Affairs Coordinator will provide expert logistics and administrative support to the Medical Affairs leadership team....

    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. Clinical Data Standards Expert at Chiltern International

      Lead the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs,…) to...

    1. Senior Consultant (Regulatory – Vault) at Veeva Systems

      Lead life sciences customers in the rapid configuration and implementation of applications to support regulatory affairs and regulatory operations content and...

    1. Sr Pharmacovigilance Scientist - Product Lead at Biogen

      Able to interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and...

      1. Science & Engineer Innovation Program -SENIOR DEVELOPMENT SCIENTIST at Beckman Coulter, Inc.

        Two rotations will be in the Research and Development Center and one rotation will be in an outside department, such as Quality, Marketing, Business Development...

      2. 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...

      3. Regulatory Affairs Specialist at Validant

        Regulatory Affairs Specialists – Primary responsibilities include:. Validant is seeking Regulatory Affairs professionals with medical device experience for...

      4. Regulatory Affairs Specialist at ACell

        Regulatory Affairs Specialist. The Regulatory Affairs Specialist assists the Head of Regulatory Affairs with US and international activities relating to...

      5. Senior Medical Writer, Regulatory Writing (Home Based) at INC Research

        Management, biostatistics, regulatory affairs, and medical affairs as necessary. Adheres to established regulatory standards, including but not....