- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence function, responsible for driving...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... related to US/Ex-US regulatory submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses… more
- Arthrex (Naples, FL)
- …and medical education in orthopedics. Arthrex is actively searching for a Sr. Project Manager , Program Manager - Regulatory Affairs who is responsible for ... Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs. Develops project objectives by reviewing project proposals and… more
- Option Care Health (Tallahassee, FL)
- …customers, our teammates, and the patients we serve.Job Description Summary:The Senior Manager , Naven health Regulatory and Quality shall have oversight ... and all Quality Nurses reporting directly to the Senior Manager of Quality and Regulatory .Job Description: Job...to the Senior Manager of Quality and Regulatory .Job Description: Job Responsibilities (listed in order of importance… more
- Dexian - Signature Consultants (San Francisco, CA)
- Job Summary:Dexian is seeking a Sr. Project Manager w/ Regulatory Reporting for an opportunity with a client located in San Francisco, CA.Responsibilities:Act as ... an advisor to leadership to develop or influence success of programs, project performance and prioritization for planning, communications, and engagements across change managementLead the strategy and resolution of highly complex and unique challenges… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital role you will prepare and coordinate the preparation of regulatory submission ... of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy… more
- Medline Industries LP (Northfield, IL)
- …life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related. Work Experience 2+ years of ... regulatory or quality experience in the medical device industry or pharmaceutical industry. Additional Willing to travel up to 10% of the time for business… more
- DivIHN Integration Inc (Lake Forest, IL)
- …Forest, IL Duration: 7 Months Description Exempt/Non Exempt: Non exemptYears. Duties: Manager regulatory submissions ot ensure timely regulatory approval ... Ensure all client product and procedures comply with applicable regulatory agency requirements and guidelines. Manager is...with applicable regulatory agency requirements and guidelines. Manager is Insun Ho Start date will be determined… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …the QC Bioassay/Virology team and managing day‐to‐day activities of team. The Manager represents QC Bioassay/Virology during customer and regulatory audits. The ... Springs, North Carolina, United States. External US About This Role The Manager , Bioassay/Virology is responsible for contributing to key functional, tactical, and… more
- Piedmont Airlines, Inc (Phoenix, AZ)
- …support to the Senior Manager , Flight and Maintenance Safety and Senior Manager , Regulatory ComplianceWork with a hub and several field city locations, ... Piedmont is seeking a motivated, reliable leader to join our team as a Manager , Ground Safety. The primary responsibility of this position is to support the Senior… more
- Creative Financial Staffing (Denver, CO)
- …maintain internal controls to safeguard company assets and ensure compliance with regulatory requirements. The Accounting Manager will prepare and analyze ... Accounting Manager Job Description: We are seeking an experienced...Coordinate and liaise with external auditors, tax consultants, and regulatory authorities as needed. Manage and mentor a team… more
- Option Care Health (Grand Rapids, MI)
- …of the Option Care, current pharmacy practice professional standards, and other regulatory entities. The Pharmacy Manager is responsible for the coordination ... a diverse workforce. Job Description Summary:**Hiring Range From $135K**The Pharmacy Manager is a licensed professional who is responsible for planning, organizing,… more
- Creative Financial Staffing (Visalia, CA)
- …for managing financial reporting, budgeting, forecasting, and ensuring compliance with regulatory requirements. The Accounting Manager will lead a team ... Accounting Manager Visalia, CA Our client, a growing organization...department heads and senior management. Compliance: Ensure compliance with regulatory standards and internal policies, including GAAP and banking… more
- Creative Financial Staffing (Columbus, OH)
- …with grace. Financial Expertise: In-depth knowledge of accounting principles and regulatory compliance. Requirements For The Accounting Manager : Strong ... Ignite Your Career as an Accounting Manager in Columbus, Ohio! Are you a seasoned...take the lead? Elevate your career as an Accounting Manager and become the orchestrator of financial success with… more
- Catalent (Manassas, VA)
- …and track result data; Report any deviations to the Quality Systems and Regulatory Manager in complete, appropriate detail; Review and verify the operators' ... paperwork to ensure they meet quality standards.Participate in all necessary training required to perform job responsibilities successfully.Other duties as assigned.The Candidate:BS in Food Science and/or related major preferred or high school Diploma with 3+… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …of raw materials and excipients, represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids ... in Holly Springs, North Carolina, United States. External US About This Role The Manager , QC Raw Materials Manager is accountable for GMP compliant laboratory… more
- Aequor (Thousand Oaks, CA)
- …activities around technology development. Enterprise level engagement. Job Title: Senior Project Manager - End to End Regulatory Content Automation Initiative, ... of 5-8 YOE in project management within R&D and regulatory affairs, within pharmaceutical. Not a tech expert but...Strategy, Position Summary: We are seeking a seasoned Project Manager with a proven track record in the pharmaceutical… more
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