Current jobs related to Regulatory Affairs Associates - Foster City - Infotree Global Solutions


  • Foster City, California, United States Fladger Associates Full time

    Job Title: CMC Regulatory Affairs Data Entry SpecialistFladger Associates is seeking a highly skilled Regulatory Affairs Data Entry Specialist to join our team in Foster City, CA. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Company RIM System to support key CMC RA stakeholders.Key...


  • Foster City, United States Fladger Associates Full time

    Description: Job Title: CMC Regulatory Affairs, Data Entry Contractor PositionContract Duration: 6 months (we would like to start with 6 months, with the potential to extend if the person is highly competent and a good resource for our team)Location: Remote- If the candidate is in the Foster City, CA area, we would prefer that they are onsite 2-3 days if...


  • Foster City, California, United States Integrated Resources, Inc ( IRI ) Full time

    Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsJob Duration: 6 MonthsJob Location: Foster City, CAResponsibilities:Prepare Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions for biologics products.Interact with departments outside of CMC Regulatory...


  • Foster City, United States Integrated Resources, Inc ( IRI ) Full time

    Job Title- Senior Manager, CMC Regulatory Affairs, BiologicsJob Duration: 6 MonthsJob Location: Foster City,CA RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products....


  • Foster City, California, United States ATR International Full time

    Regulatory Affairs Assistant - IIWe are seeking a highly skilled Regulatory Affairs Assistant - II to join our team at ATR International. This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.Key Responsibilities:Perform data...


  • Foster City, California, United States Innova Solutions Full time

    Job DescriptionInnova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Client RIM System to support key CMC RA stakeholders.Key Responsibilities:Perform data entry using Client RIM System to enter relevant...


  • Foster City, California, United States LeadStack Inc. Full time

    Job Title: CMC Regulatory Affairs Assistant II - Data EntryLeadStack Inc. is seeking a highly skilled and detail-oriented CMC Regulatory Affairs Assistant II - Data Entry to join our team. As a key member of our regulatory affairs team, you will be responsible for performing data entry using RIM System to enter relevant information to support key CMC RA...


  • Foster City, California, United States LeadStack Inc. Full time

    Job Title: CMC Regulatory Affairs Assistant II - Data EntryWe are seeking a highly skilled and detail-oriented individual to join our team as a CMC Regulatory Affairs Assistant II - Data Entry. This is a remote opportunity with the possibility of working on-site in Foster City, CA.Key Responsibilities:Perform data entry using RIM System to enter relevant...


  • Foster City, California, United States Net2Source Inc. Full time

    Job Title: CMC Regulatory Affairs ManagerNet2Source Inc. is seeking a highly skilled CMC Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our biologics products.Key Responsibilities:Prepare and submit high-quality CMC regulatory...


  • Foster City, California, United States ATR International Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Manager III to join our team at ATR International. This role will be responsible for leading the preparation of quality sections of regulatory submissions, including INDs/IMPDs, new marketing authorization applications, and post-approval variations.Key Responsibilities:Prepare high-quality...


  • Foster City, California, United States Net2Source Inc. Full time

    Job Title: CMC Regulatory Affairs ManagerNet2Source Inc. is seeking a highly skilled CMC Regulatory Affairs Manager to join our team.Job Summary:We are looking for a seasoned professional with extensive experience in CMC Regulatory Affairs to lead our team in preparing high-quality regulatory submissions for biologics products. The ideal candidate will have...


  • Foster City, California, United States Gilead Sciences Full time

    {"Responsibilities": "As a Senior Manager, Regulatory Affairs III at Gilead Sciences, you will be responsible for preparing high-quality regulatory submissions for biologics products. This includes preparing the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions. You...


  • Foster City, California, United States Innova Solutions Full time

    Job Description:As a Regulatory Affairs Assistant - II, you will be responsible for performing data entry using the Client RIM System to support key CMC RA stakeholders. You will work collaboratively with the team to execute routine data entry, such as inputting submission-related dates and regulatory assessment comments. Your tasks will include ensuring the...


  • Foster City, United States ATR International Full time

    Job DescriptionJob DescriptionWe are seeking a Regulatory Affairs Assistant - II for a very important client. Specific Job Responsibilities• Perform data entry using Gilead RIM System to enter relevant information to support key CMC RA stakeholders.• Work collaboratively to support the team by executing routine data entry, such as the input of...


  • Foster City, United States ATR International Full time

    We are seeking a Regulatory Affairs Assistant - II for a very important client.Specific Job Responsibilities• Perform data entry using Gilead RIM System to enter relevant information to support key CMC RA stakeholders.• Work collaboratively to support the team by executing routine data entry, such as the input of submission related dates, regulatory...


  • Foster City, United States ATR International Full time

    Job DescriptionJob DescriptionWe are seeking a Senior Manager, Regulatory Affairs III for a very important client. RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics...


  • Foster City, California, United States Unicon Pharma Inc Full time

    Job SummaryWe are seeking a highly organized and detail-oriented CMC Regulatory Affairs professional to join our team at Unicon Pharma Inc.The successful candidate will be responsible for performing data entry using Gilead RIM System, collaborating with the team to support key CMC RA stakeholders, and ensuring the completeness, correctness, and consistency...


  • Foster City, California, United States ATR International Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, Regulatory Affairs III to join our team at ATR International. This role will be responsible for leading the preparation of Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions for a range of biologics...


  • Foster City, United States ATR International Full time

    RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans....


  • Foster City, United States ATR International Full time

    RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans....

Regulatory Affairs Associates

3 months ago


Foster City, United States Infotree Global Solutions Full time

One of our leading Pharmaceutical client is looking for a Regulatory Affairs Associates (Data), who will be responsible for performing data entry using client Information Systems to enter and maintain relevant product information to support cross-functional stakeholders.

Job Title: Regulatory Affairs Associates (Data)

W2 Contract & Onsite role

Work Location: Foster City, CA

Required Experience:

  • Regulatory Affairs
  • Familiarity with data entry into complex information systems.
  • Should have familiarity with web-based Electronic Data Capture (EDC) and data management systems.
  • Experience with Veeva Vaults

Responsibilities:

  • Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports.
  • Ensure completeness, correctness and consistency of data and data structure.
  • Responsible for supporting project work for enhancements to information systems for RA CMC and stakeholders who utilize RA CMC data.
  • Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals.

If you are a right fit and this job excites you then please apply quick