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  • Director, International CMC Regulatory Affairs

    Cybercoders - Calabasas, CA

    Director, International CMC Regulatory Affairs If you are a Director in Regulatory Affairs CMC with international ... including regulatory impact assessments and preparation of CMC documentation for variations and other post licensure...

    30+ days ago from CyberCoders

  • CMC Regulatory Sciences Specialist

    Regeneron Pharmaceuticals - Rensselaer, NY

    responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.• Reviews ancillary CMC ... strategies – may contribute to developing CMC regulatory strategy.Knowledge and Skills:• Excellent written and...

    10 days ago from RegionalHelpWanted

  • CMC Regulatory Sciences Specialist (Early Phase)

    Regeneron Pharmaceuticals - Rensselaer, NY

    Responsible for writing, editing, and preparing CMC content for early phase regulatory submissions.Essential ... to, the following:• Authors CMC content and prepares CMC sections for early phase (phase 1 through end of phase 2...

    10 days ago from RegionalHelpWanted

  • CMC Technical Writer

    Makro Scientific - Bridgewater, NJ

    desired.The candidate must have prior experience writing CMC technical reports or CMC regulatory content or Quality ... Bio-Pharmaceutical industry.Desire 5 years experience in CMC Regulatory/technical writing. Strong communication and...

    20 days ago from Get Biology Jobs

  • Senior Director CMC

    Akebia Therapeutics - Cambridge, MA

    critical processes to ensure compliance with Akebia’s CMC and clinical supply responsibilities Essential Functions ... and lead cross-functional CMC Team(s). • CMC regulatory requirements for global drug development and comply with...

    3 days ago from Biospace

  • Associate Director/Director, Regulatory Affairs (CMC)

    Relypsa - Redwood City, CA

    reports to the Senior Director, Regulatory Affairs (CMC). Responsibilities •Responsible for the timely ... experience with pharmaceutical CMC filings for INDs and NDAs. Electronic submission experience desirable.

    6 days ago from Biospace

  • Associate Scientist/Scientist, CMC

    Dart Neuroscience - San Diego, CA

    successful candidate will be responsible for implementing CMC strategies, as well as coordinating many aspects of CMC ... preparing Chemistry, Manufacturing and Control (CMC) documentation for regulatory filings, particularly in CTD format,...

    7 days ago from Biospace


    CMC Engineering - Wilkes Barre, PA

    experience is a plus. Send fax or e-mail resume to: CMC Engineering P.O. Box 958 Kimberton, PA 19482 Fax (610) 983-9202 e-mail: construction_ EEO/AA - M/F/V/H Category: Construction, Mining &...

    7 days ago from TheJobNetwork

  • Associate Director / Director, CMC Operations

    Not-for-profit Science Advancement Organization - Burlington, MA

    process qualification at vendor sites Draft and review CMC regulatory documents, batch records, specifications, ... Biology) Minimum of eight years’ experience in CMC leadership of a pharmaceutical or biotech company Experience...

    1 day ago from IvyExec

  • Medical Writer (CMC, BLAs)

    Pioneer Data Systems - Chesterfield, MO

    We have a 36+ Months contract position for Medical Writer (CMC, BLAs) for our direct client located in Chesterfield MO ... or BLA'S (Biologic License Applications) particulary the CMC section is required. Thanks & Regards, Alex Kashyap Sr...

    30+ days ago from StartWire

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