• Omeros Corporation (Seattle, WA)
    …policies and procedures. Good things are happening at Omeros! Come join our Regulatory Affairs Team! Who is Omeros? Omeros is a commercial-stage ... regulatory agencies (NDA/MAA), setting the standards for CMC regulatory submissions to assure adequacy, completeness,...budget for approved project plans MS degree in Drug Regulatory Affairs or Regulatory Science… more
    Neuvoo (12/11/19)
    - Save Job - Related Jobs - Block Source
  • Omeros Corporation (Seattle, WA)
    … or a closely related field; Two years of professional experience as a Regulatory Affairs Associate/ Specialist in the pharmaceutical industry, including at ... and scientific and company policies and procedures. Specific responsibilities include: Perform regulatory CMC activities within time and budget for approved… more
    Neuvoo (12/07/19)
    - Save Job - Related Jobs - Block Source
  • The Emmes Company, LLC (Rockville, MD)
    The Emmes Company, LLC is searching for a Senior Regulatory Affairs Specialist . Emmes has offices located at the below locations and throughout the greater ... development through data analysis and manuscript generation. Primary Purpose The Senior Regulatory Affairs Specialist is responsible for functioning as… more
    The Emmes Company, LLC (12/04/19)
    - Save Job - Related Jobs - Block Source
  • The Emmes Company, LLC (Rockville, MD)
    The Emmes Company, LLC is searching for a Regulatory Affairs Specialist located in our Rockville, Maryland or Frederick, Maryland offices. Emmes provides ... protocol development through data analysis and manuscript generation. Primary Purpose The Regulatory Affairs Specialist is responsible for coordinating the… more
    The Emmes Company, LLC (12/04/19)
    - Save Job - Related Jobs - Block Source
  • Santen, Inc. (Emeryville, CA)
    …while ensuring conditions for meeting regulatory requirements are maintained Represent Global Regulatory Affairs CMC in the regulatory sub-team ... CMC document packages for Health authority submissions; Manages regulatory CMC activities for specific projects/products (including development, pre-market… more
    Neuvoo (12/02/19)
    - Save Job - Related Jobs - Block Source
  • Omeros Corporation (Seattle, WA)
    The Regulatory Specialist provides support by helping to develop and execute against regulatory plans for one or more products. You will provide support to ... things are happening at Omeros! Come work with our Regulatory Affairs Team! Who is Omeros? Omeros...and maintenance of program annual reports, and may support CMC , nonclinical, pharmacovigilance and other routine regulatory more
    Neuvoo (12/02/19)
    - Save Job - Related Jobs - Block Source
  • Skills Alliance (Bridgewater, VA)
    Regulatory CMC Lead - Innovative Pharmaceutical Company (Ophthalmic space) - $100,000-$125,000 Regulatory CMC Lead is actively being hired by a genuine ... the injectable and ophthalmic space based in Bridgewater, NJ. Regulatory CMC Lead will have a key...approval changes, recurrent filings: annual reports, etc. Support the Regulatory Affairs group in the development of… more
    Neuvoo (12/12/19)
    - Save Job - Related Jobs - Block Source
  • Advanced Resource Managers (Marlborough, MA)
    CMC technical and project management challenges. - 6-10 years of experience in Regulatory Affairs in a Pharma, Biopharma setting. - Understanding of ICH, FDA ... a leading Consultancy business based in Marlborough, Massachusetts. They are a specialist growing consultancy firm providing industry leading services within CMC more
    Neuvoo (12/10/19)
    - Save Job - Related Jobs - Block Source
  • Integrated Resources, Inc (Swiftwater, PA)
    …background CMC / Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3 Scientific background , ... of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC . Provide regulatory guidance for development projets, post-approval CMC changes/variations.… more
    Neuvoo (12/10/19)
    - Save Job - Related Jobs - Block Source
  • Alvogen (Pine Brook, NJ)
    …within defined procedures and policies to determine appropriate action. Represents Regulatory Affairs perspective to teams/team members to meet schedules ... team, departmental and company goals in timely manner. Represent Regulatory Affairs in project teams and provide...Affairs experience . Exhibit strong knowledge of current CMC and ANDA related regulations/guidance's . Ability to liaise… more
    PandaLogic (12/10/19)
    - Save Job - Related Jobs - Block Source
  • Akorn, Inc (Vernon Hills, IL)
    … requirements. * Review and evaluate scientific data and reports required for regulatory submissions for consistency to relevant FDA/ICH CMC guidelines. * ... Oversees and drives the development and submission of regulatory filings. Manages day-to-day activities related to organization and submission of regulatory more
    Neuvoo (12/09/19)
    - Save Job - Related Jobs - Block Source
  • ProClinical (Princeton, NJ)
    Proclinical is currently recruiting for a Clinical Regulatory Affairs Manager for a pharmaceutical company located in Princeton, NJ. Successful candidate will ... scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries. Extensive experience… more
    Neuvoo (12/04/19)
    - Save Job - Related Jobs - Block Source
  • Cleveland Heart (Cleveland, OH)
    …MS Project is a plus. Interested candidates should submit their resumes via email. Regulatory Affairs Manager Return to Jobs List Purpose of Job: Increase the ... be done by the company. Draft applicable portions of regulatory submissions (eg, CMC section for FDA,...bandwidth of the Regulatory Affairs department to aid the group… more
    Cleveland Heart (12/08/19)
    - Save Job - Related Jobs - Block Source
  • UTMB Health (Galveston, TX)
    …Information Officer as well as Director of Quality for Correctional Managed Care ( CMC ) and Texas Department of Criminal Justice (TDCJ). This position will ensure the ... and monitoring programs and activities are consistent with all relevant regulatory requirements. Oversees proactive and reactive patient safety activities including… more
    UTMB Health (11/25/19)
    - Save Job - Related Jobs - Block Source
  • Regulatory Affairs Specialist

    Randstad (Swiftwater, PA)
    Regulatory Affairs Specialist III...Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and ... + industry:Professional, Scientific, and Technical Services + reference:30129 **job description** Regulatory Affairs Specialist III job summary: **As… more
    Randstad (12/04/19)
    - Save Job - Related Jobs - Block Source
  • Regulatory Affairs Specialist

    Randstad (Swiftwater, PA)
    Regulatory Affairs Specialist III...Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and ... + industry:Professional, Scientific, and Technical Services + reference:30571 **job description** Regulatory Affairs Specialist III job summary: **As… more
    Randstad (11/26/19)
    - Save Job - Related Jobs - Block Source
  • Regulatory Affairs Specialist

    Axle Informatics (Rockville, MD)
    …accredited college or university. + Minimum of 8 years progressively responsible experience in Regulatory Affairs . + Must have at least 5 years working with ... for vaccines, monoclonal antibodies, and related biological products. + Assists regulatory program managers with CMC -relevant responses to comments from… more
    Axle Informatics (10/12/19)
    - Save Job - Related Jobs - Block Source
  • Principal Regulatory Affairs

    Philips (Maple Grove, MN)
    …+ 7+ years of medical device experience with BS degree and work experience in regulatory affairs or, 6+ years of medical device experience with MS degree and ... discipline, eg biocompatibility, mechanical testing, preclinical testing, risk management, CMC etc., or within a segment (eg CV, PV,...work experience in regulatory affairs , or 4+ years of medical… more
    Philips (12/11/19)
    - Save Job - Related Jobs - Block Source
  • Sr. Specialist , Quality…

    Integra LifeSciences (Plainsboro, NJ)
    …Quality and Regulatory Compliance Specialist will provide quality and regulatory compliance support to the CMC Plant. This function shall participate in ... Sr. Specialist , Quality & Regulatory Compliance US-NJ-Plainsboro,...regulatory agencies. The position will interface with Corporate Regulatory Affairs and provide assessments of changes… more
    Integra LifeSciences (10/26/19)
    - Save Job - Related Jobs - Block Source
  • Sr. Regulatory Specialist

    OraSure Technologies, Inc. (Bethlehem, PA)
    …of 510(k), PMA submissions, FDA pre-submissions and IDE submissions + Experience in regulatory affairs in the medical device industry OraSure Technologies is an ... Responsible for preparation of documentation (ie CMC (Chemistry, Manufacturing & Control) sections) to support...support PMA, PMA supplements, 510(k), Design Dossiers and other regulatory responses. Act as the regulatory member… more
    OraSure Technologies, Inc. (09/19/19)
    - Save Job - Related Jobs - Block Source