Manager/Sr Manager/AGM For API Regulatory Affairs Dept

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...

We seek a seasoned Regulatory Affairs Head to lead and drive the global regulatory strategy for our formulation-based pharmaceutical products across Europe and Rest of World (ROW) markets at Evertogen Life Sciences. As the Regulatory Affairs Head, you will play a crucial role in overseeing all regulatory submissions, compliance management, and lifecycle...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA...

Career CategoryRegulatoryJob DescriptionSr Manager - Gen Med / Biosims International Regulatory LeadThe Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements.Group...

Sr Manager - Gen Med Biosims International Regulatory LeadThe Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements.Group PurposeInternational Regulatory Affairs provides...

Company DescriptionMorulaa HealthTech Pvt. Ltd. was founded to assist in the commercialization of bio-science technologies and the growth of healthcare companies. Based in Ohio and collaborating with Cleveland Clinic, University Hospitals, and Case Western Reserve University, Morulaa specializes in the Registration of Medical Devices and Distributor...

The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process.Key Responsibilities:Intelligence Gathering &...

The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams toOptimize product development and regulatory approvals in International countriesDevelop...

The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of...

Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...