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Technical Resources International
Bethesda, MD, United States
Job Title MANAGER, REGULATORY AFFAIRS Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Applicatio
Job Source: Technical Resources InternationalTechnical Resources International
Bethesda, MD, United States
Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application
Job Source: Technical Resources InternationalJTI
Washington, DC, United States
Search by keyword and location and click "create alert" to receive your job alerts by email: Select how often (in days) to receive an alert: Professional area: Corporate Affairs & Communications Contract type: Permanent Professional level: Experienced Location: Washington, DC, US, 00000 We’re JTI, Japan Tobacco International and we beli
Job Source: JTIJT International S.A.
Washington, DC, United States
We're JTI, Japan Tobacco International and we believe in freedom . We think that the possibilities are limitless when you're free to choose. In fact, we've spent the last 20 years innovating, creating new and better products for our consumers to choose from . It's how we've grown to be present in 130 countries. But our business isn't just busine
Job Source: JT International S.A.Amgen
Washington, DC, United States
**HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading
Job Source: AmgenHR Retail
Bethesda, MD, United States
Regulatory Affairs Manager - (MGRRA_COMPANY_1) Share this job as a link in your status update to LinkedIn. Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multip
Job Source: HR RetailPhilip Morris USA
Washington, DC, United States
Manager Regulatory Affairs Be a part of a revolutionary change At PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. We can now provide legal a
Job Source: Philip Morris USAJTI Inc
Washington, DC, United States
We're JTI, Japan Tobacco International and we believe in freedom . We think that the possibilities are limitless when you're free to choose. In fact, we've spent the last 20 years innovating, creating new and better products for our consumers to choose from . It's how we've grown to be present in 130 countries. But our business isn't just busine
Job Source: JTI IncBethesda, MD, United States
The Johns Hopkins Health System Corporation is a not-for-profit organization dedicated to providing the highest quality of care in the treatment and prevention of human illness. JHHS is an academically based health system consisting of: The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Johns Hopkins Howard County Medical Center, Suburban Hospital, Sibley Memorial Hospital, The Johns Hopkins All Children’s Health System, Johns Hopkins Community Physicians, The Johns Hopkins Medical Services Corporation and Johns Hopkins Medical Management Corporation.
YOU BELONG HERE
What Awaits You?
Career growth and development
Employee and Dependent Tuition Assistance
Diverse and collaborative working environment
Affordable and comprehensive benefits package
Our competitive Benefit Package is designed to support the well-being and financial security of our employees. You can explore the details of our benefits offering by visiting the following link: https://jhhs.mybenefitsjhhs.com/
Summary:
This position will receive continuous guidance and mentoring by the Director of Regulatory Affairs and/or the Deputy Chief Regulatory Officer and the Chief Regulatory Officer, as applicable.
The Manager of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification processes, including but not limited to, The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), and State/Local Department of Health (DOH) standards, regulations and law, in consultation with JHHS Legal Counsel, as necessary. This position involves interpreting and operationalizing regulatory requirements, including but not limited to:
Participating in regulatory-related communication/notification, staff/leadership education, and policy/documentation development or revision as needed
Coordinating virtual and onsite surveys by external regulatory/accreditation agencies
Coordinating onsite mock surveys by external consultants or JHHS Office of Accreditation & Certification
Developing and implementing corrective actions and monitoring plans for sustaining improvements over time
Collaborating on special projects, as requested
Serving as a resource/consultant to internal and external customers
Participating in organization and/or health system committees
Education:
Requires a Bachelor’s Degree (healthcare-related preferred). Graduation from an accredited school of nursing, public health or related clinical discipline preferred.
Work Experience:
A minimum of 5 - 7 years of healthcare-related experience required
Experience in regulatory compliance, performance/quality improvement, patient safety, risk management or project management preferred.
Important Notices:
*** Effective January 1st 2022, you must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of your vaccination status as part of your occupational health screening. Exceptions to the COVID-19 vaccination requirement may be granted to individuals for religious beliefs or medical reasons by following the proper protocols. Employees at Johns Hopkins All Children’s Hospital, its affiliate locations and Florida State Residents are not required to obtain the COVID-19 vaccine . In the wake of the COVID-19 pandemic, the Johns Hopkins Health System remains committed to providing the highest quality care for our patients and our communities. We encourage you to explore our current opportunities.
***Authorization to Work in the United States: Applicants who require sponsorship now or in the future will not be considered for this position.
Johns Hopkins Health System and its affiliates are drug-free workplace employers.
We are committed to providing a healthy and safe environment for our patients, visitors and staff members. The Johns Hopkins Hospital has a tobacco-free at work policy. Employees must refrain from using any tobacco products during their work shifts — including while at lunch or on breaks, and whether they are on or off campus.
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Email Alert for Manager of Regulatory Affairs jobs in Bethesda, MD, United States
ⓘ There was an unexpected error processing your request.
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