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regulatory affairs in Boston

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    1. Director of CMC Regulatory Affairs

        Job Title: Director of CMC Regulatory Affairs             Leading pharmaceutical development company   Location: Boston, MA   Description: Provide regulatory direction and strategic technical input across all regulatory programs.   Responsibilities: Screen development of new requirements and inform senior management of impact to the company Give direction for regulatory ...

    2. Regulatory Affairs Specialist

        Hello,   My name is Alexis 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 Emeryville, CA. Details for the position are as follows:   Job Description: Seeking a Regulatory Affairs Specialist. Candidate must speak fluent Spanish, Mandarin, or ...

    3. QA  Regulatory Affairs Specialist

      QA / Regulatory Affairs Specialist This Position pays Market + Full Benefits Description Job Summary: This QA/RA Specialist is responsible for maintaining and ensuring that the company quality system meets FDA requirements for class I medical devices (IVD and ASR). The QA/RA Specialist is also responsible for ensuring that products and their labeling meet all regulatory requirements ...

    4. Regulatory Affairs Specialist

      The primary functions of the Periodic Reporting Associates (PRA) are: Leading the preparation of Periodic Safety Reports (PSR) in compliance with regulatory requirements such as Good Pharmacovigilance Practices (GPVP), ICH Guidances, FDA Guidances and Global Quality standards within established timelines. Authoring and leading the co-ordination of cross functional contributions for ...

    5. Regulatory Affairs Specialist

      Hello, My name is Sheena and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs Associate for a prominent client of ours.  This position is located in Cambridge, MA. Details for the position are as follows: Job Description: Leading the preparation of Periodic Safety Reports (PSR) in compliance with regulatory requirements such as ...

    6. Director of Regulatory Affairs Medical Device hh

      Director of Regulatory Affairs-Med-Device Boston - MA Job Description The Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategy for the regulatory functions. This position reports directly to the Sr. VP – Global Product Operations. This person manages Regulatory Affairs staff in addition to oversight responsibility for ...

    7. Prescription Drug Promotion Submission Director - Regulatory Affairs

      Lead regulatory review and submission of required documentation for FDA approval of promotional and marketing materials. Activities: *** Support a dynamic, cross-functional team actively developing new therapeutic treatments. *** Develop strategies to ensure regulatory review of all materials related to new product release, from labels to direct submission forms required by the FDA. * ...

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    8. QA Regulatory Affairs Specialist

      QA / Regulatory Affairs Specialist This Position pays Market + Full Benefits Description Job Summary: This QA/RA Specialist is responsible for maintaining and ensuring that the company quality system meets FDA requirements for class I medical devices (IVD and ASR). The QA/RA Specialist is also responsible for ensuring that products and their labeling meet all regulatory requirements ...

    9. Regulatory Affairs Associate

      Kelly Clinical Research has an exciting opportunity for a Regulatory Affairs Temp. This is a 6 month contract opportunity with the potential to extend in Mansfield, MA at a medical device company. The Regulatory Affairs Temp will coordinate activities for a variety of device regulatory approvals in association with company rebranding including: database management, labeling reviews, export ...

    10. Regulatory Affairs CMC Project Manager

        Hello,   My name is Carlane and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs CMC Project Manager I position  for a prominent client of ours.  This position is located in Lexington MA. Details for the position are as follows:   Responsibilities: Manages multiple multi-product CMC focus global submission to ensure ...

    11. Regulatory Affairs CMC Project Manager I

      Sigma Bullhorn ID: 7050 Location: Lexington Area, MA Client Industry: Biotechnology/Pharmaceuticals Position: Regulatory Affairs CMC Project Manager I Classification: 9 Months Contract (Extensions Likely Into Second Half of 2016)   PLEASE NOTE: Remote Work is NOT allowed. On-Site Only. If you have any questions, I’ll be happy to answer them, but I’ll need to see a copy of your most ‘up ...

    12. Regulatory Affairs Manager

      Regulatory Affairs Manager Kelly Scientific is partnering with a growing pharmaceutical company in Lexington, MA to fill an immediate need for a Regulatory Affairs Manager. The Regulatory Affairs Manager will serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.Responsibilities: Provide regulatory ...

    13. Regulatory Affairs Manager, CMC & Operations

      Type: Permanent Responsibilities include: Plan, author, and manage the submissions of CMC and other regulatory documents. Manage and track the progress of planned regulatory submissions to within defined timelines, in collaboration with the regulatory product leaders and cross functional teams. Participate and collaborate in cross functional teams to fulfill submission deliverables. ...