Regulatory Affairs Assistant

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...

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...

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...

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...

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...

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...

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....

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...

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...

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...

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...

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...

{"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...

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...

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...

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...

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....

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....

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....

Job DescriptionGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need.We are seeking a highly skilled Director, CMC Regulatory Affairs to lead our Biologics portfolio. As a key member of our team, you will be responsible for defining regulatory...