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416 manager regulatory operations jobs found

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Abbott Laboratories
May 16, 2023
Manager, Regulatory Operations
Abbott Laboratories Santa Clara, CA, USA
At Abbott, diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
Abbott Laboratories
May 16, 2023
Manager, Regulatory Operations
Abbott Laboratories Maple Grove, MN, USA
At Abbott, diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
Biomarin
May 09, 2023
Manager, Regulatory Operations
Biomarin San Rafael, CA, USA
With accelerated review underway in the United States and Europe for our Hemophilia A drug, a second gene therapy program entering the clinic for PKU patients, and a third program in late research for Hereditary Angioedema, BioMarin continues to pioneer innovative approaches to treating rare diseases. Our commitment to gene therapy is further underscored by having developed the first and largest gene therapy manufacturing facility in the world. The scientific possibilities and the hope we offer to patients with rare diseases is enormous. BioMarin is a midsize biotechnology company with a market cap of approximately 18 billion. Over the course of our 22 year history we have successfully launched 7 drugs for the treatment of rare diseases. Our success is due to our scientific rigor and our ability to leverage multiple therapeutic modalities. BioMarin is based in the San Francisco Bay Area and offers a comprehensive relocation program. BioMarin is the world leader in...
Allergan
May 23, 2023
Manager, Regulatory Affairs - Labeling Operations
Allergan Lake County, IL, USA
Allergan is now part of AbbVie. As one company, we have brought together over 30 brands and leadership positions, expanding and diversifying our product portfolio. Join us in making a remarkable impact on people’s lives around the world. As two great companies combine forces, we’ve centralized the job search experience to help us find world-class talent interested in working every day to discover and address many of the world’s most pressing health challenges. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Daiichi Sankyo Company
May 09, 2023
Manager, Dossier Planning Regulatory Operations
Daiichi Sankyo Company Bernards, NJ, USA
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin,...
Biomarin
May 09, 2023
Temporary Regulatory Affairs Business Operations & Processes Project Manager
Biomarin San Rafael, CA, USA
With accelerated review underway in the United States and Europe for our Hemophilia A drug, a second gene therapy program entering the clinic for PKU patients, and a third program in late research for Hereditary Angioedema, BioMarin continues to pioneer innovative approaches to treating rare diseases. Our commitment to gene therapy is further underscored by having developed the first and largest gene therapy manufacturing facility in the world. The scientific possibilities and the hope we offer to patients with rare diseases is enormous. BioMarin is a midsize biotechnology company with a market cap of approximately 18 billion. Over the course of our 22 year history we have successfully launched 7 drugs for the treatment of rare diseases. Our success is due to our scientific rigor and our ability to leverage multiple therapeutic modalities. BioMarin is based in the San Francisco Bay Area and offers a comprehensive relocation program. BioMarin is the world leader in...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Stockton, CA, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Springfield, MA, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Somerville, NJ, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Seattle, WA, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Richmond, VA, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Remote
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Phoenix, AZ, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Morristown, NJ, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Kansas City, MO, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Fairfield, CA, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
Mallinckrodt
May 23, 2023
Technical Services Engineer
Mallinckrodt Columbus, OH, USA
The Technical Service Engineer will be responsible for maintaining, repairing and servicing equipment in an assigned geography and other areas as needed. On-going training and support will be provided to the Technical Services Engineer.  Our product is positioned to grow and the service organization will be required to mirror that growth with customer support. Essential Functions The incumbent will provide direct on-site assistance to customers within assigned geography and other areas as needed.  Will have the ability to work in a hospital environment, mainly within large academic hospital outpatient areas.  Manage instrument installations in conjunction with the clinical service team, territory manager and the customer. Responsible for managing service operations to meet or exceed key performance indicators (KPIs) established by management; this includes oversight of third party provider,  who performs most of service activities including...
CSL Behring
May 23, 2023
Contract Center Physician
CSL Behring Memphis, TN, USA
In the absence of the center manager, this position has ultimate responsibility of entire center operations, including production, quality compliance, finance, HR and IT. In most centers, the Assistant Manager will have primary responsibility for day-to-day center operations. Serves as the main management support to CSL Plasma services center manager Ensures on-going improvements and act as liaison with all corporate functions to ensure center compliance and performance Job Description • In the absence of the center manager, overall authority over center operations production goals, monitor net yields and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain operational records. • Independently determine center labor usage to meet business needs. Support meeting the established center production goals. • In collaboration with center manager, manage all inventories to the optimum levels by maximizing efficiencies,...
CSL Behring
May 23, 2023
Contract Center Medical Director/Center Physician, Backup
CSL Behring Rochester, NY, USA
In the absence of the center manager, this position has ultimate responsibility of entire center operations, including production, quality compliance, finance, HR and IT. In most centers, the Assistant Manager will have primary responsibility for day-to-day center operations. Serves as the main management support to CSL Plasma services center manager Ensures on-going improvements and act as liaison with all corporate functions to ensure center compliance and performance Job Description • In the absence of the center manager, overall authority over center operations production goals, monitor net yields and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain operational records. • Independently determine center labor usage to meet business needs. Support meeting the established center production goals. • In collaboration with center manager, manage all inventories to the optimum levels by maximizing efficiencies,...
CSL Behring
May 23, 2023
Contract Center Medical Director/Center Physician, Backup
CSL Behring Lackawanna, NY, USA
In the absence of the center manager, this position has ultimate responsibility of entire center operations, including production, quality compliance, finance, HR and IT. In most centers, the Assistant Manager will have primary responsibility for day-to-day center operations. Serves as the main management support to CSL Plasma services center manager Ensures on-going improvements and act as liaison with all corporate functions to ensure center compliance and performance Job Description • In the absence of the center manager, overall authority over center operations production goals, monitor net yields and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain operational records. • Independently determine center labor usage to meet business needs. Support meeting the established center production goals. • In collaboration with center manager, manage all inventories to the optimum levels by maximizing efficiencies,...
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