Regulatory Affairs Coordinator

4 days ago

Kearny, NJ, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Regulatory Labelling Documentation.
  • Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions.
  • Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling projects in close collaboration with GLM/GL-TAL.
  • Independently coordinate the timely delivery of compliant documentation (Clinical Overviews, Nonclinical Overviews, SCE, SCS, PSUR, published literature, Expert CVs, Signature Pages, etc.) to support the regulatory labelling submissions worldwide. Order English translations of non-English literature as needed.
  • Guide and support the GLM/GL-TAL, GPRD/GPRM and cross-functional experts with the review of CLP and SRP documents to ensure compliance with state-ofthe-art regulatory requirements and company standards, including formal QC.
  • Independently enter and maintain current information on the labelling project in Ops RADAR including the planned global dispatch date of CLP/SRP.
  • Contribute to the planning and supervision of the Phase 1 milestones for Safety Label Changes and obtain SLC Tracking Numbers from GL Compliance and Artwork Team
  • Independently prepare the Reference lists for the Core Data Sheets in compliance with current documentation standards.
  • Independently exchange regulatory documents and collaborate directly with other client divisions and license partners on behalf of GLM/GL-TAL according to collaboration agreements. Monitor the GL Mailbox for new communications from license partners and forward these to the appropriate GLM/GL-TAL.
  • Create and maintain GL functional and product-specific labeling archives. Global Labeling Committee.
  • Independently prepare and communicate the annual schedule of GLC and Joint GLC/MSRB meetings.
  • Independently coordinate with CLP authors and GPTs the scheduling of topics for GLC and Joint GLC/MSRB review and prepare/maintain the agendas of GLC and Joint GLC/MSRB meetings.
  • Organise the logistics of GLC and Joint GLC/MSRB meetings and distribute meeting invitations with pre-reads to the GLC (and MSRB, if applicable) members.
  • Pro-actively ensure that CLP authors and GPTs prepare program-team-agreed draft contributions to the GLC and Joint GLC/MSRB meeting minutes and manage the workflow of GLC Chair review/input, GLC(/MSRB) review, finalization, distribution and archiving of the meeting minutes.
  • Independently coordinate the timely off-line GLC review of appropriate labeling changes as agreed with the GLC Chair, compile and archive the feedback received.
  • Exchange planning information and documentation directly with the members of the GLC, MSRB, GPTs as needed.
  • Excellence and Compliance.
  • Contribute to global labeling management and continuous improvement initiatives. Review and comment on emerging internal process documents and labeling standards.
  • Ensure compliance of CLPs with global regulatory labeling requirements and adherence to regulatory internal policies and processes.
  • Provide adequate support during HA inspections and own or foreign company audits, such as compiling and archiving documentation, etc.
  • ct as administrator and superuser for regulatory and labeling-specific databases.
  • Organize and lead as subject matter expert tutorial training sessions for RA GL newcomers.
  • Provide administrative support to GLM, GL-TAL and Head GL as needed.
Requirements:
  • Minimum of 3 - 5 years of related pharmaceutical / regulatory affairs experience.
  • Prior publishing/Regulatory Operations experience beneficial.
  • Good communication and negotiation skills.
  • Proactive personality.
  • Fast and flexible, focused on high quality and timely delivery and stretch targets.
  • bility to plan and prioritise workload'
  • bility to work in a matrixed environment.
  • bility to build effective relationships across teams/projects.

  • Authorization Specialist

    1 week ago

    Kearny, NJ, United States BrightSpan Health Full time

    Why BrightSpan? At BrightSpan Health, our mission is to bridge the gap between clinical care and operational clarity-empowering providers through expert revenue cycle solutions that ease administrative burdens, restore peace of mind, and make room for what matters most: their clients. We're not just managing claims-we're shaping futures for providers, their...

  • Authorization Specialist

    1 week ago

    Kearny, NJ, United States BrightSpan Health Full time

    Why BrightSpan? At BrightSpan Health, our mission is to bridge the gap between clinical care and operational clarity-empowering providers through expert revenue cycle solutions that ease administrative burdens, restore peace of mind, and make room for what matters most: their clients. We're not just managing claims-we're shaping futures for providers, their...

  • Logistics Coordinator

    6 days ago

    Kearny, United States Raycap Inc Full time

    The Logistics Coordinator is responsible for ensuring shipments are executed on time while maintaining an organized and efficient floor. This role requires a proactive, hands-on individual who actively utilizes SAP to track shipments, update statuses, and identify opportunities to maximize floor space. The Logistics Coordinator communicates regularly with...

  • Logistics Coordinator in Kearny

    4 weeks ago

    Kearny, United States Energy Jobline ZR Full time

    Overview Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide. We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear...

  • Quality & Food Safety Supervisor

    4 weeks ago

    Kearny, United States Bunge Full time

    City : Kearny State : New Jersey (US-NJ) Country : United States (US) Requisition Number : 41532 A Day in the Life: Supervise and coordinate the Quality Assurance department in support of and alongside the Quality & Food Safety Manager, specifically the laboratory and food/feed safety program. The position is responsible for plant food and feed safety,...

  • Payroll & Benefits Assistant

    2 weeks ago

    Kearny, United States Grace Healthcare Services Full time

    Company: Grace Healthcare ServicesLocation: Kearny, NJJob Type: Full-time, On-site (Monday to Friday, 8:30 AM - 5:00 PM)About the Role: Grace Healthcare Services is looking for a detail-oriented and organized Payroll and Benefits Assistant to join our team. In this role, you will support payroll processing and benefits administration for over 100 employees,...

  • Registered Nurse

    6 days ago

    Kearny, United States Clara Maass Medical Center Full time

    Job Title: RN Location: Clara Maass Medical Center Department Name: Nursing Supervisors Req : Status: Hourly Shift: Day Pay Range: $46.48 - $62.09 per hour Pay Transparency: The above reflects the anticipated hourly wage range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on...

  • Chief Geologist

    17 hours ago

    Kearny, United States ASARCO Full time

    The Chief Geologist leads all mine-site geological activities for a high-tonnage open-pit, Cu-porphyry-skarn, processing sulfide ore by flotation. Emphasis is on short-range grade control and ore routing, geometallurgical domaining, resource growth, rigorous data collection/QAQC, and timely geological inputs to mine planning. The role reports to the...

  • Dispatcher

    1 week ago

    Kearny, United States AmerisourceBergen Corporation Full time

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • Chief Geologist

    2 weeks ago

    Kearny, United States ASARCO Full time

    Chief Geologist – Copper Resource The Chief Geologist leads all mine‑site geological activities for a high‑tonnage open‑pit, Cu‑porphyry‑skarn, processing sulfide ore by flotation. Emphasis is on short‑range grade control and ore routing, geometallurgical domaining, resource growth, rigorous data collection/QAQC, and timely geological inputs to...

  • IT/OT Infrastructure Manager

    4 days ago

    Kearny, AZ, United States Turner Mining Group Full time

    IT/OT Infrastructure Manager Job Description: Turner Staffing Group is partnered with a mining company in Arizona that is looking for an IT/OT Infrastructure Manager to oversee enterprise-wide infrastructure including servers, storage systems, data centers, virtualization platforms, backups, and cybersecurity across both Information Technology (IT) and...

  • Psychiatrist - Inwood Health Center (Part-Time)

    3 weeks ago

    Kearny, United States Sun River Health Full time

    Job DescriptionAbout Sun River HealthSun River Health has a rich history of providing quality, affordable health care to communities in need. Founded in the early 1970s by four African American women in Peekskill, New York, our organization was established to address the lack of accessible health services in their community. Over the years, Sun River Health...