Regulatory Operations Specialist

4 weeks ago


Princeton, New Jersey, United States Joulé Full time
Job Title: RA/QA Operations Specialist

We are seeking a highly organized and detail-oriented RA/QA Operations Specialist to join our team at Joule. This is a full-time, hybrid position in Princeton, NJ.

Responsibilities:
  • Conduct regulatory document filing and processing
  • Perform administrative functions for the RA/QA department, including expense submission preparation and file department training documents
  • Format and word-process regulatory submission documents to meet eCTD standards
  • Maintain files of department correspondence, contracts, and other administrative information
  • Make travel arrangements and submit expense reports
Requirements:
  • Associate degree preferred
  • Minimum 2 years of administrative experience with knowledge of regulatory operations or RA/QA administrative work
  • Pharmaceutical or biotechnology company background or experience preferred
  • Proficiency in MS Office, Adobe Acrobat, and other technical skills

This is a direct hire position with a salary range of $50,000-$55,000 per year. If you are a detail-oriented and organized individual with experience in regulatory operations, we encourage you to apply.

Technical Skills:
  • Proficiency in MS Office, Adobe Acrobat, EDMS, ISIToolBox, and ISIWriter
  • Knowledge of regulated document preparation and pharmaceutical industry a plus

We are an equal opportunity employer and welcome applications from diverse candidates.



  • Princeton, New Jersey, United States Avance Consulting Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Avance Consulting. The successful candidate will be responsible for supporting necessary submission activities for CTAs under the EU CTR.Key ResponsibilitiesPrepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory...


  • Princeton, New Jersey, United States Avance Consulting Full time

    Job Title: Regulatory Affairs ManagerJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to support our client in the preparation and submission of Clinical Trial Applications (CTAs) within the EU Clinical Trial Regulation (CTR) framework.Key Responsibilities:* Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS)...


  • Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewLynkx Staffing LLC is seeking a highly experienced Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to lead global teams in developing and executing regulatory strategies for pharmaceutical clients.Develop and implement regulatory strategies for CMC components of drug development programs, collaborating with project teams and...


  • Princeton, New Jersey, United States State Street Full time

    Role OverviewWe are seeking a highly skilled Regulatory Reporting Officer to join our team at State Street. As a key member of our regulatory reporting team, you will be responsible for assisting our clients with meeting their regulatory reporting obligations.Key ResponsibilitiesParticipate in client-facing project calls to discuss regulatory reporting...


  • Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Senior Regulatory Counsel to join our team.Job SummaryThe Senior Regulatory Counsel will be responsible for providing legal support to different...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Sun Pharmaceutical Industries, Inc. as a key member of our Regulatory Affairs team!We are seeking a highly skilled Senior Manager, Regulatory Affairs to handle publishing and coordinating tasks for Global RA submission activities. This role will support the Global RA submission process and infrastructure.Must be able to multi-task and coordinate for...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    The Senior Director, Global Regulatory Portfolio Lead, will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. This role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA. The successful candidate will serve as a key corporate...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Senior Director, Global Regulatory Portfolio Lead will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. This role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA.Key Responsibilities Serve as key corporate...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Director, Global Regulatory Portfolio LeadThe Senior Director, Global Regulatory Portfolio Lead, is a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA. This role is responsible for providing leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more...


  • Princeton, New Jersey, United States Ryder Full time

    Warehouse Operations SpecialistRyder is seeking a highly skilled Warehouse Operations Specialist to join our team in Princeton, Kentucky. As a key member of our logistics and distribution team, you will be responsible for ensuring the efficient and safe operation of our warehouse facilities.Key Responsibilities:Operate a sit-down forklift to move materials...


  • Princeton, New Jersey, United States Best Buy Full time

    As a Warehouse Operations Specialist at Best Buy, you will be responsible for ensuring the efficient flow of products from receipt to shipment. This includes unloading trucks, recording inventory, and preparing products for shipment to other stores and customers. You will also be responsible for stocking shelves and organizing merchandise displays to help...


  • Princeton, New Jersey, United States Diversity Nexus Full time

    Job Title: Specialist, QA EngineeringLocation: Warren NJAssignment Length: 12 monthsRequirements:B.S. degree required1 - 3 years of experience in the pharmaceutical or related industryEquivalent combination of education and experience acceptableKey Responsibilities:Experience with QA oversight on key software development (SDLC) processes such as problem,...

  • Validation Specialist

    3 weeks ago


    Princeton, New Jersey, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Title: Validation SpecialistJob Summary: We are seeking a highly skilled Validation Specialist to join our team at Futran Tech Solutions Pvt. Ltd. The ideal candidate will have a strong background in computer system validation, regulatory compliance, and quality assurance.Key Responsibilities:Apply FDA, MHRA, and other applicable global health authority...


  • Princeton, New Jersey, United States NRG Full time

    Job Title: Power Trading SpecialistNRG is seeking a highly motivated Power Trading Specialist to join our team. As a key member of our commercial operations team, you will be responsible for supporting a broad range of activities, including wholesale pricing, customer reporting, scheduling, market analysis, modeling, and research.Key Responsibilities:Manage...


  • Princeton, New Jersey, United States Educational Testing Service Full time

    About ETS ProcurementEducational Testing Service (ETS) is a leader in the education sector, and we are seeking a skilled Procurement Specialist to join our team. As a Procurement Specialist, you will play a critical role in ensuring the timely and cost-effective acquisition of goods and services for our organization.Key ResponsibilitiesProcurement Planning:...


  • Princeton, New Jersey, United States Mathematica Policy Research Full time

    We are seeking a highly organized and detail-oriented Administrative Support Specialist to join our team at Mathematica Policy Research.The successful candidate will provide administrative support to our data collection staff, including data entry, quality control, and field support. This is a part-time position working on-site at our Princeton office...


  • Princeton, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full time

    At Syneos Health/inVentiv Health Commercial LLC, we are seeking a highly skilled and experienced Senior Operations Supervisor to join our team. This role will be responsible for overseeing the day-to-day operations of our laboratory, ensuring that all activities are conducted in accordance with regulatory requirements and company policies.The ideal candidate...


  • Princeton, New Jersey, United States SRI International Full time

    Job Summary:The Microcircuit Emulation Center at SRI International is seeking a skilled Wafer Fabrication Operations Specialist to support the manufacturing of microcircuits on-site in Princeton, NJ. This role offers opportunities to develop knowledge and skills through internal mentoring and training.Responsibilities:Perform hands-on work in support of...


  • Princeton, New Jersey, United States SRI International Full time

    Job Summary:The Microcircuit Emulation Center at SRI International is seeking a skilled Wafer Fabrication Operations Specialist to support the manufacturing of microcircuits on-site in Princeton, NJ. This position offers opportunities to develop a career in semiconductor manufacturing with internal mentoring and training.Responsibilities:Perform hands-on...


  • Princeton, New Jersey, United States Target Full time

    Job SummaryAs a Security Specialist at Target, you will contribute to a secure work environment by executing routines to identify and investigate theft, and advancing Assets Protection partnerships through professional interaction.Key ResponsibilitiesContribute to a team in the development of a secure work environment for all Target team members, temporary...