CMC Global Regulatory Affairs Manager

Position: Senior Manager, Regulatory Affairs III*Location: Foster city, CADuration: 06+ Months (Extendable) Projected for 06 months and beyond depending on the business need.This Position is HYBRID Pay Rate: $85-100.00/hr on W2 Paid weekly (Without Benefits included in the pay you will have you buy them separately by paying price for the benefits)Client:...

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...

The CMC Regulatory Affairs Project Manager will be responsible for tracking the status of key filings for clinical and commercial programs for all global markets. Other responsibilities include: 1) facilitate communication of regulatory activities across CMC Sub-Teams and Senior Management; 2) work on an improved tool for the regulatory department to track...

The CMC Regulatory Affairs Project Manager will be responsible for tracking the status of key filings for clinical and commercial programs for all global markets. Other responsibilities include: 1) facilitate communication of regulatory activities across CMC Sub-Teams and Senior Management; 2) work on an improved tool for the regulatory department to track...

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....

{"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 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 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 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...

About the Role:The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix team of professionals, who work with a specific product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide leadership at a product level as a global lead that ensures right first time global...

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...

Job Title: Senior Manager, Regulatory Affairs IIIWe are seeking a highly skilled Senior Manager, Regulatory Affairs III to join our team at ATR International.Key Responsibilities:Prepare high-quality CMC sections for INDs/IMPDs, marketing authorization applications, post-approval variations, renewals, and responses to agency questions.Collaborate with...

Job OverviewWe 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....

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 assessment comments.• Ensure completeness, correctness and consistency of...

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...

Intern CMC Regulatory Affairs - BiologicsUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with...