Regulatory Affairs Associate

**Job Purpose**: Thisrole provides operational support for the implementation within GlobalRegulatory Affairs of the Internal Control Framework (ICF) elements such asrisk assessment, written standards and control, training, management monitoring(MM) and responding to problem (CAPA/CC/deviation management) also supportingregulatory community in internal...

Role description:Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this...

Hyderabad **Job ID**: SS202500077 **Function**: Quality **Role**: Regulatory Affairs **Desired Skills**: Regulatory, EU-MDR, Document, International Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in...

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 patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the...

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...

MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region...

Career Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure compliance...

Career CategoryRegulatoryJob DescriptionWhat you will doThe Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgen's CMC & Device Regulatory Team in Amgen India (AIN). This role provides leadership across multiple functional interfaces and global sites, ensuring that AIN...

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...

What you will doThe Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgen's CMC & Device Regulatory Team in Amgen India (AIN). This role provides leadership across multiple functional interfaces and global sites, ensuring that AIN staff are supported, connected, and...