Senior Manager, Global Regulatory Writing

Join Amgen's Mission of Serving PatientsAt 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 diseases. With our focus on four therapeutic...

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...

Position Summary The Global HEOR Value Writing Senior Associate plays a critical role in supporting Amgens global market access strategy through high-quality Health Technology Assessment (HTA) deliverables. This role collaborates closely with team lead and Global HEOR Product Leads to ensure alignment with product strategy. The Value Writing Senior Associate...

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the...

Position Summary The Global HEOR Value Writing Manager plays a critical role in supporting Amgens global market access strategy through high-quality Health Technology Assessment (HTA) deliverables.This role collaborates closely with Global HEOR Product Leads to ensure alignment with product strategy. The Value Writing Manager develops Global Value Dossiers...

Position Summary The Global HEOR Value Writing Manager plays a critical role in supporting Amgens global market access strategy through high-quality Health Technology Assessment (HTA) deliverables. This role collaborates closely with Global HEOR Product Leads to ensure alignment with product strategy. The Value Writing Manager develops Global Value Dossiers...

Job title: Senior Medical Regulatory WriterLocation: 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: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial productsThe RA CMC Manager is responsible for communicating the regulatory strategy,...

SummaryThe Senior International Regulatory Excellence Manager (Senior IREM) supports strategic guidance and regulatory expertise to country regulatory operations across International region with the objective to strengthen and promote compliance with regulatory standards and increase their operational efficiency.The Senior IREM supports thelocal and regional...

Roles & Responsibilities:Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional teamEnsure consistent quality across documents, ensure submission readiness, and...