Lead - Global Regulatory Intelligence

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 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...

Sr Associate Regulatory Affairs - International Regulatory Lead Career CategoryRegulatory Job Description ABOUT AMGEN Amgen 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...

Manager, Global Regulatory Writing Career CategoryRegulatory Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech...

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations.Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle...

Job title: Regulatory Data Model Governance LeadLocation: HyderabadOpella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.  Our mission is to bring health in people's hands by making self-care as simple as it should be. For half a billion consumers...

Career CategoryRegulatoryJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest...

*The Team:*You will be part of a World Class IT Services & Operations team supporting various product offerings of S&P Credit Solutions and S&P Capital IQ powered by various middle tier, database and OS technologies and used by tens of thousands of users globally. The team is responsible for ensuring Greater Reliability, High Performance, High Availability...

About the Role: Grade Level (for internal use):11 The Role: The Knowledge Engineering team are seeking a Lead Knowledge Engineer to support our strategic transformation from a traditional data organization into a next generation interconnected data intelligence organization. The Team: The Knowledge Engineering team within data strategy and governance...

What you will doIn this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standardsWrite or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)Write CTD sections including the Summary of...