Senior Manager, Regulatory Affairs Specialist

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: 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 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...

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...

{"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: 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 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 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...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Gilead Sciences, Inc. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring compliance with governing laws, regulations, and company policies while enabling the business to meet its goals and objectives.Key...

Job Title: Senior Manager, Global Medical AffairsJob Summary:Gilead Sciences is seeking a highly skilled Senior Manager, Global Medical Affairs to join our team. This role will be responsible for managing and overseeing projects related to global medical affairs, including late phase programs, clinical trials, and medical communications.Key...

Job Title: Regulatory Affairs SpecialistAt Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing global regulatory strategies for medical device products.Key Responsibilities:Develop global...

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...

Revolution Medicines: A Leader in Precision OncologyWe are a clinical-stage precision oncology company dedicated to developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.The OpportunityThe Senior Associate, Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspects of the...

Revolution Medicines: A Leader in Precision OncologyRevolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies to combat RAS-addicted cancers. Our research pipeline focuses on RAS(ON) Inhibitors and RAS Companion Inhibitors, designed to suppress diverse oncogenic variants of RAS proteins and...

Revolution Medicines: A Leader in Precision OncologyRevolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies to combat RAS-addicted cancers. Our research pipeline focuses on RAS(ON) Inhibitors and RAS Companion Inhibitors, designed to suppress diverse oncogenic variants of RAS proteins and...

Company OverviewPulmonx is a global leader in interventional pulmonology, specializing in innovative tools and treatments for obstructive lung disease. With operations in multiple countries, Pulmonx is renowned for developing the Zephyr Valve, a device that has received breakthrough designation from the FDA due to its significant advantages in non-surgical...

Company OverviewPulmonx is a global frontrunner in the field of Interventional Pulmonology, offering innovative tools and treatments for obstructive lung diseases. With headquarters in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is renowned for its development of the Zephyr Valve, a device that has received breakthrough designation and FDA...

Job SummaryCorcept Therapeutics is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the company's regulatory interface with domestic and international health authorities.Key ResponsibilitiesManage the development and deployment of the regulatory...