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Philip 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 IncJT 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.JTI
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: JTIAmgen
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 RetailJohns Hopkins Medicine
Bethesda, 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, Sub
Job Source: Johns Hopkins MedicineTechnical 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 InternationalBethesda, 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 Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
Coordinates the tracking, compiling, and reviewing of regulatory submissions including, but not limited to New INDs, BLA, NDS, IDEs, Annual Reports to INDs and Protocol Reviews for accuracy, completeness and quality.
Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
Supervises and manage Regulatory Team staff members, as assigned.
Leads and participates in projects as assigned to optimize regulatory processes and facilitate best practice approaches to drive functional excellence.
Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.
Coordinates the maintenance of work process tools to promote efficiency and productivity.? These may include templates, SOPs, work instructions, checklists, trackers, etc.
Performs literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
Provides regulatory and project management support for projects as needed.
Coordinates across projects as needed to ensure harmonization and knowledge sharing.
Provides oversight for the tracking of regulatory activity, database maintenance, and ensure that records are complete, accurate, and current.
Supports the preparation and review of technical proposals.
Job Requirements Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
Superior organizational skills and customer service abilities.
Ability to analyze medical research data and review experimental protocols.
Strong working knowledge of Microsoft office; experience with SharePoint a plus.
Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus.
Experience in preparing regulatory documents, publishing regulatory submissions using?electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.?
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.
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Email Alert for Regulatory Affairs Manager jobs in Bethesda, MD, United States
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