Regulatory Affairs Director Global CMC

About the RoleAmgen is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of strategy for the CMC and Device Regulatory Affairs team. This role will ensure strategic alignment across programs and geographies, representing the CMC and Device Regulatory Affairs team with Amgen leadership, governance bodies, regulatory...

Job SummaryAmgen is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of strategy for the CMC and Device Regulatory Affairs team. This role will oversee the development of regulatory strategies, decisions, and implementation plans for the Obesity portfolio.Key ResponsibilitiesDevelop and execute regulatory strategies...

Job Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Accordance Search Group. As a key member of our regulatory team, you will be responsible for providing comprehensive regulatory support for new product launches and existing product lines.Key Responsibilities:Develop and implement global regulatory strategies for...

Job Title: Regulatory SpecialistJob Summary:We are seeking a highly skilled Regulatory Specialist to join our team at Accordance Search Group. The successful candidate will provide comprehensive regulatory support for new product launches and existing product lines, collaborating with cross-functional teams to ensure compliance with regulatory...

Job Title: Senior Director, Regulatory Risk ServicesAmgen is seeking a highly skilled Senior Director, Regulatory Risk Services to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Develop and implement regulatory strategies...

Key Responsibilities:The Senior Director of Global Strategic Procurement will lead the development of strategic plans and execution for ~$3 B spend, partnering with Amgen's core business functions R&D and ATMOS (Digital Medical, Sa Director, Sourcing, Executive, Strategic, Global, Business Operations, Business ServicesKey Skills:Strategic planning and...

Clinical Development Director OpportunityCapsida Biotherapeutics is a pioneering company developing targeted, non-invasive IV administered gene therapies. Our mission is to advance a new class of treatments for genetic diseases, including potential best-in-class therapies for genetic epilepsy and Parkinson's disease.The Clinical Development Director will...

Defy Imagination with a Career at AmgenAt Amgen, we're driven by a shared mission to serve patients. We're a global collaborator, researching, manufacturing, and delivering innovative products that reach over 10 million patients worldwide.Key Responsibilities:Provide strategic analytical leadership to teams developing commercial manufacturing processes for...

Transform the Lives of Patients with AmgenAt Amgen, we're driven by a shared mission to serve patients living with serious illnesses. As a member of our team, you'll contribute to advancing the fight against the world's toughest diseases.About the RoleWe're seeking a highly skilled and experienced Director of Biologics Process Development to lead our team in...

Job SummaryThe Director of Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance, and Supplier Quality Teams in ensuring the implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance-related activities at the site.Key ResponsibilitiesManage the Quality Systems and...

Job Title: Director Process DevelopmentJob Summary:Amgen is seeking a highly skilled Director Process Development to lead the development and advancement of a large and diverse portfolio of biologic therapeutic molecules from research to IND and enable GMP supply for early clinical trials. The ideal candidate will have a strong background in...

Job SummaryThe Director of Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance, and Supplier Quality Teams in ensuring the implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance-related activities at the site.Main ResponsibilitiesManage the Quality Systems and...

Job SummaryThe Director of Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance, and Supplier Quality Teams in implementing a phased appropriate program. This individual will be a quality expert for compliance and compliance-related activities at the site.Key ResponsibilitiesManage the Quality Systems and Compliance functions,...

Job SummaryThe Director of Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance, and Supplier Quality Teams in ensuring the implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance-related activities at the site.Key Responsibilities:Manage the Quality Systems and...

Job Summary:The Global Trade Licensing Manager will lead a team of licensing analysts to assess international business requirements, prepare export license applications, and apply appropriate use of license exceptions when available. This position will have 2-3 direct reports and will primarily focus on efforts related to the Export Administration...

Director of Occupational HealthAmgen is seeking a highly skilled and experienced Director of Occupational Health to join our team. As a key member of our Environment, Health and Safety (EHS) team, you will be responsible for the management and delivery of direct patient care at our Occupational Health Clinic in Thousand Oaks, CA, as well as oversight of two...

About the RoleWe are seeking a highly experienced and skilled professional to lead our obesity and diabetes development efforts. As the Vice President, Obesity and Diabetes, you will be responsible for driving the late clinical development strategy, planning, and decision-making for pipeline products with targeted indications of weight management and...

Job SummaryWe are seeking a highly skilled Quality Control Associate to join our team at Infotree Global Solutions. As a key member of our laboratory team, you will be responsible for performing routine laboratory procedures, analytical testing, and maintaining equipment.Key ResponsibilitiesVerify instrument performance and maintain equipmentFollow all...

Job Title: Project Engineer Medical DeviceWe are seeking a highly skilled Project Engineer Medical Device to join our team at Infotree Global Solutions.Job Summary:The Project Engineer Medical Device will be responsible for supporting and creating project schedules, dashboards, and leading team meetings to progress the project final objectives. This will...

Job Title: Senior Technical LeadJob Summary:We are seeking a highly skilled Senior Technical Lead to join our team at Infotree Global Solutions. As a Senior Technical Lead, you will be responsible for planning, executing, and reporting test activities for combination product teams.Key Responsibilities:Coordinate with technical leads and cross-functional...