Regulatory Affairs CMC Information Systems Coordinator

Position Overview:As a Lead Manager in CMC Regulatory Affairs at Gilead Sciences, you will play a pivotal role in steering the strategic direction and operational execution of regulatory initiatives within the Chemistry, Manufacturing, and Controls (CMC) domain.Key Responsibilities:1. Oversee the preparation and submission of intricate regulatory CMC...

Head of CMC Regulatory Affairs- Small MoleculeUnited States – RemoteGilead 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...

Senior Director, CMC Regulatory Affairs Biologics Project LeadUnited 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...

Company Overview:LeadStack Inc. is a highly regarded staffing services provider, recognized as one of the fastest-growing certified minority-owned businesses in the nation. We pride ourselves on being a certified Great Place to Work and collaborating with esteemed Fortune 500 companies.Position:Regulatory Affairs Associate IILocation:Foster City, CAContract...

Join a leading biotechnology firm as a Regulatory Compliance Associate focused on CMC (Chemistry, Manufacturing, and Controls) to enhance our Data Administration efforts.Key ResponsibilitiesConduct data entry utilizing internal systems to accurately input and maintain essential product details for various stakeholders.Collaborate effectively with the...

A leading biotechnology organization is seeking a Regulatory Affairs Specialist (CMC) to enhance the Data Administration team. This position offers a hybrid work arrangement.Key ResponsibilitiesConduct data entry utilizing internal systems to accurately input and maintain essential product details for cross-departmental collaboration.Collaborate effectively...

About the RoleWe are seeking a highly experienced and skilled Regulatory Affairs Director to lead our CMC Regulatory strategy for Adverum's gene therapy program/s. As a key member of our team, you will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of our development program/s.Key...

**About the Role**HealthCare Recruiters International is seeking a highly qualified Director of Regulatory Affairs to join our team. As a key member of our R&D team, you will play a critical role in the development and commercialization of innovative robotic systems for the diagnosis and treatment of patients with advanced surgical interventions.**Key...

Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsUnited 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...

Position OverviewThe Senior Director of Regulatory Affairs for Advertising & Promotion will lead, guide, and provide strategic direction on all advertising and promotional initiatives, ensuring adherence to regulations, alignment with approved product registrations, and compliance with company policies throughout the product lifecycle. This role will...

Associate Director, Regulatory Affairs - InflammationUnited 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...

Director, Regulatory Affairs - InflammationUnited States - California - Foster CityUnited States - New Jersey - ParsippanyGilead 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...

Company OverviewPulmonx is a leading innovator in Interventional Pulmonology, Planning Tools, and Treatments for Obstructive Lung Disease. Based in the United States and Switzerland, Pulmonx is the manufacturer of the Zephyr Valve. The Zephyr Valve was granted breakthrough status and approved by the FDA in 2018, as it represents a breakthrough technology...

Manager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative tools and therapies for Obstructive Lung Disease. Our commitment to excellence is exemplified by our flagship product, the Zephyr Valve, which has been recognized for its groundbreaking technology in the realm of...

About PulmonxPulmonx is a leading medical device company dedicated to developing innovative solutions for respiratory health. We are seeking an experienced Regulatory Affairs Director to join our dynamic team.Key ResponsibilitiesRegulatory Strategy Development: Develop and implement comprehensive regulatory strategies that align with company goals and ensure...

Manager, Regulatory Affairs, InternationalPulmonx is a recognized leader in the field of Interventional Pulmonology, specializing in innovative tools and therapies for obstructive lung diseases. Our flagship product, the Zephyr Valve, has received significant accolades, including breakthrough designation from the FDA due to its unique approach to lung volume...

Company OverviewPulmonx is a pioneering organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. With operations in multiple locations, Pulmonx is renowned for developing the Zephyr Valve, a device that has achieved breakthrough designation from the FDA, recognized for its significant...

Manager, Regulatory Affairs, InternationalPulmonx is a recognized leader in the field of Interventional Pulmonology, specializing in innovative planning tools and treatments for obstructive lung diseases. With operations in multiple global locations, Pulmonx is renowned for its Zephyr Valve, a device that received breakthrough designation from the FDA in...

Manager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a device that has achieved breakthrough status and received FDA approval due to its significant...

Manager, Regulatory Affairs, InternationalPulmonx is a leading organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a groundbreaking device that received breakthrough designation from the FDA in June 2018, as it...