Job Type
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QA/QC Associate-regulatory Affairs Jobs

35 Jobs

  • 3.3
    Akorn – Amityville, NY
    $56k-$80k(Glassdoor est.)
    NEW
    FDA and other regulatory agencies. Interact with Research & Development, Quality Assurance/Quality Control (QA/QC), and Production… compliance with regulatory guidelines. Generate Standard Operating Procedures (SOP’s) as needed for the RegulatoryAffairs group. Remain…
  • 4.2
    Smith Hanley Associates – Bridgewater, NJ
    HOT
    Associate or Senior Associate Global RegulatoryAffairs CMC Biologics Location: Westborough, MA Industry: Pharmaceutical Job Category… and clinical biological products. Senior Associate Global RegulatoryAffairs CMC Biologics Key Responsibilities: 1.Coordinate…
  • 5.0
    Pinpoint Pharma – Lake Forest, IL
    $42k-$62k(Glassdoor est.)
    16 days ago 16d
    technical departments (R&D, QA/QC) and outside firms. Collaborate with 3rd party companies for US regulatory submissions. Critically… Job Code: #227 Title: RegulatoryAffairsAssociate Date Posted: 10/03/2017 Job Type: Contract Job…
  • 4.5
    TalentBurst – Allston, MA
    7 days ago 7d
    provide recommendation to key stakeholders. Regulatory, Manufacturing, QA/QC experience Proficient in MS Word, Excel, PowerPoint… Reporting to the Associate Director, Global Regulatory CMC, this position will provide Regulatory CMC support for the Allston…
  • 3.8
    Planet Pharma – Allston, MA
    $48k-$72k(Glassdoor est.)
    NEW
    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…
  • 4.3
    bluebird bio – Cambridge, MA
    $66k-$92k(Glassdoor est.)
    NEW
    biostatistics, medical writing, safety, regulatoryaffairs, and pharmaceutical science and QA team members, both internally and externally… functions including Pharmacovigilance, Cell Procurement, CMC, QC/QA, and Supply Chain. Collaborate with Clinical Development,…
  • 2.6
    Raritan Pharmaceuticals – East Brunswick, NJ
    $52k-$76k(Glassdoor est.)
    13 days ago 13d
    with Research & Development, Quality Assurance/Quality Control (QA/QC), and Production for gathering data and documentation. Review… Review and audit data submitted by technical departments (R&D, QA/QC) and outside firms. Assist in developing draft labeling for…
  • 3.1
    Sanofi U.S. – Westborough, MA
    $62k-$116k(Glassdoor est.)
    HOT
    paced environment on multiple product lines Manufacturing, QA/QC experience #LI-SA Sanofi US Services, Inc. and its U.… Description This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls…
  • Advanced Bio-Logic Solutions Corp – Thousand Oaks, CA
    14 days ago 14d
    Senior AssociateRegulatoryAffairs to work in our Global RegulatoryAffairs group. The Senior AssociateRegulatoryAffairs will… testing (QC/QA or clinical), or distribution Pharmaceutical/Biotechnology industry; 3-5 years regulatory CMC specific regulatory knowledge…
  • 4.3
    CPS (cps4jobs.com) – Chesterfield, MO
    $79k-$117k(Glassdoor est.)
    23 days ago 23d
    with manufacturing and QA/QC in enhancing quality management systems to facilitate overall regulatory compliance. *Interacts… activities of the RegulatoryAffairsAssociates for North America. *Drafts, maintains, and updates regulatory guidelines, positions…
  • 3.3
    PENTAX Medical – Montvale, NJ
    $66k-$92k(Glassdoor est.)
    NEW
    , Marketing, and North America Operations QA/QC groups in determining that regulatory requirements are met. Provide support for… submissions and audits. Maintain RegulatoryAffairs product files to support compliance with regulatory requirements. Work under general…
  • 3.3
    Celerion – Tempe, AZ
    NEW
    ISF Perform Quality Control (QC) on all regulatory binders before the Quality Assurance (QA) audit of critical documents is… study documents that are received and taken from the RegulatoryAffairs Coordinator. Shall maintain and update all study related…
  • 4.7
    Russell Tobin – Montvale, NJ
    24 days ago 24d
    , Marketing, and North America Operations QA/QC groups in determining that regulatory requirements are met. Provide support for… degree preferred RAC preferred Minimum of 5 year’s regulatoryaffairs experience In depth experience with FDA requirements…
  • 4.7
    Russell Tobin – Montvale, NJ
    24 days ago 24d
    , Marketing, and North America Operations QA/QC groups in determining that regulatory requirements are met. Provide support for… equivalent, Master’s degree preferred Minimum of 4 year’s regulatoryaffairs experience In depth experience with FDA requirements…
  • 3 Key Consulting – Thousand Oaks, CA
    EASY APPLY
    14 days ago 14d
    Senior AssociateRegulatoryAffairs to work in our Global RegulatoryAffairs group. The Senior AssociateRegulatoryAffairs will… testing (QC/QA or clinical), or distribution Pharmaceutical/Biotechnology industry; 3-5 years regulatory CMC specific regulatory knowledge…
  • 4.2
    Smith Hanley Associates – Westborough, MA
    14 days ago 14d
    paced environment on multiple product lines 6.Manufacturing, QA/QC experience 7.Security Clearance Not Required 8.Visa Candidates… Global RegulatoryAffairs CMC Basic Qualifications: 1.University degree in scientific discipline with 3-5 years regulatory experience…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    $89k-$142k(Glassdoor est.)
    14 days ago 14d
    Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and… Senior RegulatoryAffairs Specialist - RT Santa Clara, California 95052 Senior RegulatoryAffairs Specialist - RT IDEAL…
  • 3.1
    Sanofi U.S. – Westborough, MA
    $90k-$131k(Glassdoor est.)
    9 days ago 9d
    years of RegulatoryAffairs or relevant industry experience Master's degree and at least 1 year of RegulatoryAffairs or relevant… paced environment on multiple product lines Manufacturing, QA/QC experience Ability to effectively interpret guidance and provide…
  • 3.3
    PENTAX Medical – Montvale, NJ
    $86k-$118k(Glassdoor est.)
    22 days ago 22d
    , Marketing, and North America Operations QA/QC groups in determining that regulatory requirements are met. Provide support for… subordinate RA Associates with dotted line reporting structure. Lead projects to develop and implement documented regulatoryaffairs processes…
  • 3.6
    Sanofi – Westborough, MA
    $75k-$108k(Glassdoor est.)
    27 days ago 27d
    years of RegulatoryAffairs or relevant industry experience Master's degree and at least 1 year of RegulatoryAffairs or relevant… fast paced environment on multiple product lines Manufacturing, QA/QC experience Ability to effectively interpret guidance and provide…
  • 3.6
    Sanofi – Westborough, MA
    $64k-$120k(Glassdoor est.)
    27 days ago 27d
    fast paced environment on multiple product lines Manufacturing, QA/QC experience #LI-SA Sanofi US Services, Inc. and its U.S. affiliates… Description This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls…
  • 4.0
    SP Industries, Inc. – Warminster, PA
    22 days ago 22d
    with manufacturing and QA/QC in enhancing quality management systems to facilitate overall regulatory compliance. Drafts, maintains… teams representing the regulatoryaffairs responsibility Develop, document, and implement regulatory strategies for new technologies…
  • 3.3
    Thermo Fisher Scientific – Petaluma, CA
    $81k-$129k(Glassdoor est.)
    10 days ago 10d
    and corporate Quality and RegulatoryAffairs to ensure participation in and understanding of associated initiatives. Participates… broad-based organizational involvement. Manages the QC lab, factory quality and the QA teams (4-6 direct reports; 20 indirect) Implement…
  • 2.7
    AMRI – Albany, NY
    $81k-$110k(Glassdoor est.)
    NEW
    interacts with the various AMRI site quality units (QC, QA, RegulatoryAffairs, etc…), R&D and manufacturing to collect and assess… transparency and provides them with tools to address basic quality/regulatory requests (e.g. administrative information, off-the-shelf information…
  • 3.1
    Intarcia Therapeutics, Inc. – Hayward, CA
    $70k-$169k(Glassdoor est.)
    10 days ago 10d
    builds relationships with internal stakeholders within QC, QA, RegulatoryAffairs, Development, Manufacturing and with external vendors… submissions. Partners with RegulatoryAffairs and QA to address responses to regulatory requests. Drives regulatory strategy and submissions…
  • 2.9
    TechUSA – Malvern, PA
    NEW
    with QA Document Control, QC, Manufacturing, Plant Logistics, Validation/Engineering, Compliance and RegulatoryAffairs to ensure… EN285, GAMP4, cGEPs, HVAC systems, high purity water systems, QC/Manufacturing equipment. Experience with TrackWise, DocSpace…
  • 3.2
    Asce – South Plainfield, NJ
    $64k-$103k(Glassdoor est.)
    NEW
    quality check services for in-house regulatory submission documents provided by CMC, RegulatoryAffairs (RA), other departments, and… implement, manage and support a QC strategy and plans that contribute to PTC’s ability to maintain regulatory compliance and ensure quality…
  • 3.2
    PTC Therapeutics – South Plainfield, NJ
    $111k-$173k(Glassdoor est.)
    8 days ago 8d
    Providesquality check services for in-house regulatory submission documents provided byCMC, RegulatoryAffairs (RA), other departments, and Quality… required. Providesguidance to others performing QC activities on regulatory submission documents. Performsactivities according…
  • Ipsen Bioscience, Inc. – Cambridge, MA
    22 days ago 22d
    Manufacturing, QA/QC, Medical, etc.) to update registered product information. Evaluate site change controls, assess regulatory impact… and senior management. Liaise closely with Global RegulatoryAffairs (GRA), as needed, to assure timely, robust and accurate…
  • 3.7
    Celgene – Warren, NJ
    16 days ago 16d
    establish in-house process and QC review capacities to support CAR-T product release partnering with QA. This qualified candidate will… batch records and product associated documents for clinical CAR-T product release partnering with QA. •Review analytical data…
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