Regulatory Affairs Director

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 SummaryAs a member of the BioSpace, Inc. team, you will play a key role in shaping the company's regulatory strategy and ensuring compliance with global regulations. The ideal candidate will have a strong background in CMC regulatory affairs and experience in leading cross-functional teams.Key ResponsibilitiesDevelop and execute CMC regulatory strategies...

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...

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...

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...

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...

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...

Job Summary:As a Quality Assurance Manager at Accordance Search Group, you will lead and manage the Quality Affairs team, ensuring consistent, high-quality product designs and manufacturing. Your responsibilities will include developing and enhancing processes and procedures, overseeing incoming inspections, and building strong partnerships across R&D,...

Job OverviewSunline Transit Agency is seeking a highly skilled Accounting and Financial Reporting Manager to join our team. The successful candidate will be responsible for leading the development and implementation of financial reporting strategies, ensuring compliance with regulatory requirements, and providing financial insights to inform business...

About the RoleAs a Charge Nurse at Belmont Village, you will oversee and manage the clinical and care aspects of our community, supporting the Director of Nursing in wellness initiatives, regulatory compliance, and quality monitoring.You will coordinate and communicate with healthcare practitioners, ancillary providers, pharmacies, family members, and staff...

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

The OpportunityAt Abbott, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Irving, TX or Abbott Park, IL.What You'll Work OnParticipate as the regulatory functional product team member for the organization's Transfusion Medicine regulatory team.Support necessary regulatory activities required for product market entry...

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

The Opportunity Our location in Irving, TX or Abbott Park, IL currently has an opportunity for a Senior Regulatory Affairs Specialist. What You’ll Work On Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Supports necessary regulatory activities required for...

The Opportunity This position works out of our Lake Bluff, IL (Abbott Park) location in the Transfusion Medicine Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision...

The Opportunity This position works out of our Lake Bluff, IL (Abbott Park) location in the Transfusion Medicine Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision...

The Opportunity Manage within the Medical Affairs Sub-Function. Focus is on synthesizing and advancing scientific and clinical knowledge within diabetes for both internal and external stakeholders. What You'll Work On • The Medical Affairs Manager will be responsible for advancing and maintaining scientific and clinical knowledge, with a...

The OpportunityAbbott is seeking a highly skilled Medical Affairs Manager to join our team. As a key member of our Medical Affairs Sub-Function, you will be responsible for advancing and maintaining scientific and clinical knowledge within diabetes for both internal and external stakeholders.Key Responsibilities• Synthesize and advance scientific and...

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...

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 in our fight against the world’s toughest diseases. With our focus on...

Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...

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 in our fight against the world’s toughest diseases. With our focus on...

HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

Title: Senior Human Factors Engineer - AMAGJP00013164Locations: Remote Duration: 12 months to begin with Job Description:Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination...

Title: Senior Human Factors Engineer - AMAGJP00013164Locations: Remote Duration: 12 months to begin with Job Description:Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination...

In this dynamic role, the Sr. Associate, Research Talent Operations will support the design, management, and enhancement of early career talent programs across the Research organization. Working closely with the Director of Early Career Talent & Strategic Alliances, this position bridges strategic initiatives with operational excellence, fostering a culture...

In this dynamic role, the Sr. Associate, Research Talent Operations will support the design, management, and enhancement of early career talent programs across the Research organization. Working closely with the Director of Early Career Talent & Strategic Alliances, this position bridges strategic initiatives with operational excellence, fostering a culture...

In this dynamic role, the Sr. Associate, Research Talent Operations will support the design, management, and enhancement of early career talent programs across the Research organization. Working closely with the Director of Early Career Talent & Strategic Alliances, this position bridges strategic initiatives with operational excellence, fostering a culture...