Regulatory Affairs and QA Coordinator Jobs | Glassdoor
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Regulatory Affairs and QA Coordinator Jobs

117 Jobs

  • 2.9
    Shire – Lexington, MA
    $166k-$224k(Glassdoor est.)
    5 days ago 5d
    the direction of the Head of the OpU, direct and manage RegulatoryAffairs activities for developing and executing CMC strategies… pharmaceutical industry with a minimum of 7 years in CMC regulatoryaffairs and a strong biologics or small molecule background. Medical…
  • 4.1
    Percussionaire – Sandpoint, ID
    EASY APPLY
    $51k-$83k(Glassdoor est.)
    HOT
    company is seeking a RegulatoryAffairs Manager (salary range 75,000-90,000). As the RegulatoryAffairs Manager with this fast… Supervise Regulatory team. • Other duties as assigned Qualifications: • Regulatoryaffairs experience in the Medical Device industry…
  • 4.3
    Agios Pharmaceuticals – Cambridge, MA
    $94k-$136k(Glassdoor est.)
    HOT
    Medical Information and Managed Care Information Manager, Medical Affairs Location Agios Pharmaceuticals HQ Job Code… Medical Information and Managed Care Information Manager, Medical Affairs Agios (agios.com) is a biopharmaceutical company committed…
  • 3.0
    Sanofi U.S. – Westborough, MA
    $111k-$159k(Glassdoor est.)
    18 days ago 18d
    and assuring that regulatory submissions are on time and high quality. Additional duties include coordination with our global… control assessments Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments…
  • 3.9
    Henry M. Jackson Foundation – Bethesda, MD
    $50k-$75k(Glassdoor est.)
    5 days ago 5d
    HJF is seeking a Senior RegulatoryAffairs Specialist which serves as a research regulatory oversight subject matter expert… reviewers, review notifications); regulatorycoordination (work with other regulatory offices to coordinate reviews); problem-solving;…
  • 3.3
    Smith & Nephew – Andover, MA
    $52k-$75k(Glassdoor est.)
    NEW
    Licenses/Certifications RAC desirable (RegulatoryAffairs Certification-RegulatoryAffairs Professional Society) Experience… Instructions for Use, in coordination with key stakeholders (product development teams, marketing, R&D, QA, labeling specialists,…
  • 4.3
    CPS (cps4jobs.com) – Chicago, IL
    $54k-$80k(Glassdoor est.)
    5 days ago 5d
    Refreshes training for current regulatoryaffairs associates and trains new associates *Coordinates new ingredient approvals, USDA… Job Description RegulatoryAffairs and Labeling Specialist The RegulatoryAffairs and Labeling Specialist is responsible…
  • 4.3
    Harvest Technical – San Rafael, CA
    13 days ago 13d
    submissions. Research regulatory requirements. Skills: Minimum of 2 years’ experience in RegulatoryAffairs in the biotechnology… Job Description Harvest Technical is seeking a RegulatoryAffairs Associate II for our biotech client in the Greater Bay Area.…
  • 3.3
    Akorn, Inc. – Amityville, NY
    $56k-$80k(Glassdoor est.)
    NEW
    compliance with regulatory guidelines. Generate Standard Operating Procedures (SOP's) as needed for the RegulatoryAffairs group.… in FDA and other regulatory agencies that may impact product line. Organize and maintain RegulatoryAffairs department files.…
  • 3.0
    Natus Medical Incorporated – Seattle, WA
    $56k-$87k(Glassdoor est.)
    NEW
    support and backup for other QA/RA functions. * Supports internal/external audits and regulatory inspections. * Perform other… SUMMARY: The RegulatoryAffairs Specialist is responsible for obtaining US and OUS product clearances as well as maintaining Technical…
  • 3.4
    Verathon – Bothell, WA
    $81k-$122k(Glassdoor est.)
    HOT
    the newest member of the QA/RA Team located in our Bothell, WA headquarters. The Senior RegulatoryAffairs Specialist is responsible… Senior RegulatoryAffairs Specialist - Verathon® Verathon® is looking for a Senior RegulatoryAffairs Specialist to become…
  • 4.3
    Harvest Technical – San Rafael, CA
    9 days ago 9d
    internal RegulatoryAffairs and Project Management processes, identify opportunities for improvement. Coordination across multiple… Project Manager, RegulatoryAffairs for our Biotech client in the Greater Bay Area. Duties: Our RegulatoryAffairs organization,…
  • 3.9
    UC San Diego Health – San Diego, CA
    $46k-$72k(Glassdoor est.)
    NEW
    the RegulatoryAffairs Specialist. The regulatory submissions will be maintained and filed electronically to FDA. In QA GCP… protocol has a study coordinator who is responsible for organizing and implementing the protocol. The RegulatoryAffairs Specialist (RAS…
  • 4.3
    Smith Hanley Associates – Bridgewater, NJ
    22 days ago 22d
    Global RegulatoryAffairs CMC Biologics Key Responsibilities: 1.Coordinate and prepare document dossiers for regulatory submissions… Global RegulatoryAffairs CMC Biologics Basic Qualifications: 1.Bachelor's degree and at least 3 years of RegulatoryAffairs or relevant…
  • 3.3
    OmniGuide – Lexington, MA
    $59k-$85k(Glassdoor est.)
    NEW
    supervision Global RegulatoryAffairs Compliance Certification (GRACP) preferred. Reports to Vice President, QA/RA This position… The Global RegulatoryAffairs Specialist will be responsible for generating and maintaining all the regulatory registration…
  • 5.0
    Xencor – San Diego, CA
    $103k-$141k(Glassdoor est.)
    16 days ago 16d
    integration of RegulatoryAffairs across all the operative functions, including clinical development, CMC, QA, and preclinical development… We seek a Director, Regulatoryaffairs to work directly with department representatives on the Project Team to assure integration…
  • 3.4
    BD – San Jose, CA
    $93k-$130k(Glassdoor est.)
    5 days ago 5d
    Description The Sr. RegulatoryAffairs Specialist will be responsible for the preparation and approval of regulatory submissions required… are aligned with region/country need; BDB integrated RegulatoryAffairs Operating Plan (iRAOP) and Annual Strategic Review (ASR…
  • 3.3
    Medix – Omaha, NE
    EASY APPLY
    20 days ago 20d
    The RegulatoryAffairsCoordinator is responsible for supporting RegulatoryAffairs Specialists and Technologists with the standards… certifications Collaborate with product development, labeling, sales, QA and supply chain functions to advise on documentation needs and…
  • 4.0
    Insperity – Tucson, AZ
    27 days ago 27d
    Executive Director of RegulatoryAffairs & Quality Assurance (pharma) You have high expectations for yourself and your career… infectious disease. Reporting to the CEO, you will be our RegulatoryAffairs and Quality Assurance leader and be responsible for developing…
  • 2.9
    Shire – Lexington, MA
    10 days ago 10d
    Head, Clinical Vendor QA & Compliance. 5% Regulatory Agency Inspection Support Supports regulatory agency inspections activities… Medical Affairs programs. Lead the execution of the audit activities associated to GCP, GPP, and applicable regulatory requirements…
  • 4.5
    PureTech Health – Boston, MA
    $74k-$132k(Glassdoor est.)
    10 days ago 10d
    Description: The Head of Global RegulatoryAffairs will lead, create and drive the regulatory strategy for the resTORbio programs… maintaining the highest ethical, regulatory and scientific standards. As the head of Global RegulatoryAffairs, you will be a member of…
  • 3.7
    Apple & Associates – Fall River, MA
    NEW
    matters pertaining to quality and regulatoryaffairs. Day-to-day management and development of QA/QC programs Overall responsibility… custom products has an immediate opening for a Quality and RegulatoryAffairs Manager to join their executive team. The successful candidate…
  • 3.9
    LFB – Southborough, MA
    $73k-$125k(Glassdoor est.)
    12 days ago 12d
    effectiveness of the Quality Systems. Assists in coordinatingregulatory inspections and preparation. Assist in the management… oversight of the raw material program, vendor qualifications and QA inspection to confirm compliance with industry standards and regulations…
  • 3.9
    Noblis – Frederick, MD
    $87k-$137k(Glassdoor est.)
    13 days ago 13d
    directly to the JPEO-CBD. Noblis ESI is seeking a qualified RegulatoryAffairs Manager for support to the Joint Program Executive Office… organization, planning, assessment, and management of regulatoryaffairs (i.e., FDA) and quality assurance activities to support…
  • 2.9
    Sun Pharmaceutical Industries – Hawthorne, NY
    $134k-$180k(Glassdoor est.)
    NEW
    Represent Regulatory Head in meetings and discussions as designated. Provide regulatory guidance to R&D, Clinical, QA and QC as… Integrity. Passion. Innovation. Summary: Director, RegulatoryAffairs (CMC and Labeling) for Taro Pharmaceuticals, a subsidiary…
  • 4.2
    UC San Diego – San Diego, CA
    $50k-$77k(Glassdoor est.)
    NEW
    the RegulatoryAffairs Specialist. The regulatory submissions will be maintained and filed electronically to FDA. In QA GCP… protocol has a study coordinator who is responsible for organizing and implementing the protocol. The RegulatoryAffairs Specialist (RAS…
  • 3.5
    Panasonic North America – Newark, NJ
    $148k-$199k(Glassdoor est.)
    6 days ago 6d
    Director, RegulatoryAffairs & Quality Assurance. Panasonic has a unique opportunity for an experienced Director, Regulatory Affairs… appropriateness, and providing QA approval for top management review and approvals. Coordinating document and record control activities…
  • 3.5
    Boehringer Ingelheim – Duluth, GA
    $63k-$99k(Glassdoor est.)
    6 days ago 6d
    functions, QA, Manufacturing and other teams within RegulatoryAffairs External influence in trade organization or regulatory professional… questions from regulatory authorities where appropriate. Provide regulatory CMC expertise during RegulatoryAffairs negotiations…
  • 3.8
    Planet Pharma – Allston, MA
    $48k-$72k(Glassdoor est.)
    4 days ago 4d
    of experience in regulatory, manufacturing, technical development or QA/QC In-depth knowledge of regulatory requirements for… of experience in regulatory, manufacturing, technical development or QA/QC In-depth knowledge of regulatory requirements for…
  • 3.3
    PENTAX Medical – Montvale, NJ
    $64k-$90k(Glassdoor est.)
    6 days ago 6d
    submissions and audits. Maintain RegulatoryAffairs product files to support compliance with regulatory requirements. Work under general… equivalent, Masters degree preferred Minimum of 4 years regulatoryaffairs experience In depth experience with FDA requirements…
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