- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created ... submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal departments on … more
- BeOne Medicines (Trenton, NJ)
- …Excellence plays a pivotal role for driving the successful execution of Global Regulatory Operations Strategy & Innovation programs and projects in a dynamic ... required. + 7+ years in the pharmaceutical/bio-pharmaceutical industry with prior Regulatory Operations related experience preferred. **Computer Skills:** High… more
- Insmed Incorporated (San Diego, CA)
- …of continuous learning, cross-training, and operational excellence.In partnership with Regulatory Operations , and/or third-party service providers, ensure high ... and for the future of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams,… more
- BeOne Medicines (Emeryville, CA)
- …Compliance and is responsible for driving program-level compliance initiatives, monitoring regulatory operations , and ensuring alignment with global health ... expectations. This role provides compliance oversight and guidance across Regulatory Operations , Regulatory Affairs, Quality, Safety/Pharmacovigilance,… more
- Insmed Incorporated (NJ)
- …all stages of product development, including Research, Preclinical, Clinical, Regulatory , Operations , Quality Assurance.Innovative thinking and an ... we're in. Are you?About the Role:Reporting to the Director of Technical Operations , Project Management this position will be responsible for leading life-cycle… more
- Capco, a Wipro Company (Baltimore, MD)
- …Syndicated Loans + Leveraged Loan Middle Office (Closures) + Collateral Management + Regulatory Operations + Client Onboarding & Reference Data Management + ... the Role** We are seeking an Analyst/Associate to join our Capital Markets Operations team in Baltimore. This is an exciting opportunity for someone interested in… more
- Teleflex (Morrisville, NC)
- …and other internal groups to investigate and recommend solutions to address potential regulatory issues. - Ensure all operations are fully compliant with license ... Sr Regulatory Affairs Specialist **Date:** Oct 22, 2025 **Location:**...healthcare. For more information, please visit **teleflex.com** . **Global Operations -** Global Operations is a complex… more
- The Pivot Group (Coopersville, MI)
- …advancement. Required Skills: *Process Improvement *Six Sigma *Offers *Search *Business Operations * Regulatory Compliance *Daily Operations * Operations ... Description: Are you a dynamic leader with a passion for optimizing business operations and driving organizational success? The Pivot Group Network is dedicated to… more
- GRAIL (Durham, NC)
- …the organization including but not limited to all-Quality, Clinical Laboratory Operations , Technical Operations , Regulatory Affairs, Compliance, ... This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, supporting, and improving GRAIL's… more
- Commonwealth Care Alliance (Boston, MA)
- …+ Strong understanding of **Medicare, Medicaid (MassHealth), and dual-eligible program operations ** , including regulatory and compliance requirements. + ... management, the LTSS Program Manager ensures that providers meet contractual, regulatory , and quality standards that optimize member outcomes and operational… more
- Xcel Energy (Welch, MN)
- …that the changes are technically accurate, applicable, and in conformance with regulatory requirements and applicable Operations Writer's Guides. Further, the ... looking for. **Position Summary** This position is responsible for Nuclear Operations procedure preparation, maintenance, and reviews. Also performs all aspects of… more
- Organon & Co. (Jersey City, NJ)
- … operations while partnering with adjacent organizations such as Trade Operations , Procurement, Regulatory Material Compliance and External Manufacturing, as ... also on Instagram! Follow us at Organon (@organonllc). The US Supply Chain Operations Department consists of two branches: Distribution & Logistics Operations … more
- ExxonMobil (Spring, TX)
- …the Environmental & Regulatory team, air compliance staff in the BUs, operations , operations and division management, engineering, and Law **What you will ... Prepare guidance and training on air permitting requirements for BU regulatory & operations staff + Assist in environmental audits, compliance tracking &… more
- Insmed Incorporated (NJ)
- …CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations , and Program Management to drive ... is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.What You'll Do: Provide strategic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard… more
- Alameda Health System (Oakland, CA)
- …vendors or external partners. Fulfill additional responsibilities that advance departmental operations , regulatory readiness, or organizational goals. This may ... strategic oversight of department-wide education, clinical competencies, quality assurance, regulatory compliance, PACS/RIS workflow support, and radiologic student training… more
- Organon & Co. (Jersey City, NJ)
- …with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs, chemistry, manufacturing and control (CMC), ... 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical and/or… more
- Endo International (Horsham, PA)
- …maintains batch documentation, operational procedures, and records to support site operations . + Participates in Regulatory inspections/audits as the ... live their best life. **Job Description Summary** The Associate Director, Manufacturing Operations will provide leadership and management of operations at the… more
- Insmed Incorporated (NJ)
- …the individual will also work closely with quality, finance, procurement, regulatory , engineering, operations , consultants and outside vendors.What You'll Do: ... from concept to implementation, ensuring that our packaging meets all regulatory requirements, protects product integrity, and enhances user experience. The… more
- Insmed Incorporated (NJ)
- …teams. This individual will provide scientific support to clinical development and operations , regulatory and quality assurance teams, as well as overall ... review of information to support the development and updates for regulatory documents (ie IND submissions, IND Annual Updates, DSUR, Investigator Brochures,… more
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