- Establish Dossier Plans for the assigned global submission types as needed to support the lifecycle of one or more products.
- Generate dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
- Ensure relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
- Ensure dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
- Support development of departmental work practices, process enhancements, and associated training materials.
- Develop/maintain associated process tools and relevant training documentation.
- Support compliance needs as appropriate. Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements; Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission; Participate on special projects and process improvement initiatives, as needed.
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Operations Manager
1 week ago
Eclipse Enterprises Long, United StatesCurrently, we are looking for a plant manager for our renowned client located near Tönning. · Your responsibilities · Professional and disciplinary management of approximately 80 employees · Implementation and monitoring of operational processes · Identification and implementatio ...
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Operations Manager
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Clean Harbors Signal Hill, United StatesHPC-Industrial, powered by Clean Harbors in Long Beach CA is looking for an Industrial ServicesOperations Manager to join their safety conscious team This team member will plan, lead, organize and coordinate all duties associated with daily branch operations to include but not l ...
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Operations Manager
4 days ago
SMS Holdings Long Beach, United StatesJob Description · Would you like to earn a great living while making a difference in Long Beach, CA? · Do you believe that one great interaction can make someone's day? WE DO TOO. We're looking for an Operations Manager that has a special blend of customer service, management a ...
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Operations Manager
6 days ago
MV Transportation Long Beach, United StatesOverview: · If you reside in California, please see our California Applicant Privacy Policy for more information about our data handling practices and your data rights. · Responsibilities: · MV Transportation is seeking an Operations Manager will provide support, leadership an ...
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Operations Manager
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Eleven Recruiting Los Alamitos, United StatesAbout Eleven Recruiting · We are a specialized technology staffing agency supporting Aerospace, Professional, and Financial Services companies. We listen and act as advisors for our candidates on how they can best add value, find interesting projects, and pave a path for career a ...
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Operations Manager
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Michaels La Habra, United States Temps pleinStore - LA-LA HABRA, CAQue ferez-vous? · Offrir une expérience de magasinage centrée sur la clientèle en gérant et en · obtenant une exploitation de l'aire des caisses efficace et en respectant les attentes. · Diriger les processus omnicanaux. Maintenir les normes de rangement ...
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Facilities Operations Manager
3 days ago
Laserfiche Long Beach, United StatesLaserfiche · is a leader in software, committed to excellence. Our dedication to innovation and top-notch service is reflected in every aspect of our operations. We are seeking a highly skilled and experienced Facilities Operations Manager to join our dynamic team and manage our ...
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Night Operations Manager
13 hours ago
City Wide Long Beach, United StatesCity Wide of Southwest Los Angeles · is seeking a full-time · Night Operations Manager · to join our team The Night Operations Manager will oversee accounts in the South LA territory to coordinate service providers in our accounts, help maintain our high quality standards and ...
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Building Operations Manager
5 days ago
JLL Long Beach, United StatesJLL supports the Whole You, personally and professionally. · Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology to our clients. We are committed to hiring the best, most talented people in our indu ...
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Entertainment Operations Manager
6 days ago
ASM Global Long Beach, United StatesEntertainment Operations Manager$80,000 - $120,000 · EXTENSIVE EXPERIENCE IN ARENA, PERFORMING ARTS, AND THEATRE PREFERRED · Job Description: · As an Entertainment Operations Manager at the Long Beach Convention and Entertainment Center, you will be responsible for the day-to- ...
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Senior Operations Manager
7 hours ago
Rocket Lab USA Long Beach, United StatesABOUT ROCKET LAB · Rocket Lab is a global leader in launch and space systems. The rockets and satellites we build and launch enable some of the most ambitious and vital space missions globally, supporting scientific exploration, Earth observation and missions to combat climate ch ...
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Facilities Operations Manager
3 days ago
Laserfiche Long Beach, United States· Laserfiche is a leader in software, committed to excellence. Our dedication to innovation and top-notch service is reflected in every aspect of our operations. We are seeking a highly skilled and experienced Facilities Operations Manager to join our dynamic team and manage our ...
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Assistant Operations Manager
4 weeks ago
LBCT LLC Long Beach, United StatesJob Description · Job DescriptionPOSITION SUMMARY: · The Assistant Manager, Operations is an essential member of the management team responsible for directing and supervising ILWU Longshore personnel for any/all assigned operations, including but not limited to: vessel, yard, gat ...
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Senior Operations Manager
3 days ago
Rocket Lab Long Beach, United StatesABOUT ROCKET LAB · Rocket Lab is a global leader in launch and space systems. The rockets and satellites we build and launch enable some of the most ambitious and vital space missions globally, supporting scientific exploration, Earth observation and missions to combat climate c ...
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Operations Manager
4 days ago
Code Ninjas Los Alamitos, United StatesWe are looking for an Operations Manager who can help create a community and a welcoming environment for our students and families. The Operations Manager will manage the classroom/instructors during operational hours, coach and train a team of instructors, and ensure students ar ...
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Manager, Operations
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TPIRC and FAI Los Alamitos, United StatesJob Description · Job DescriptionJob Title: Operations Manager · Reports To: Chief Operating Officer Job purpose: · The Operations Manager will be responsible for ensuring smooth and efficient operation of the Sublingual Immunotherapy (SLIT) department, from managing inventory an ...
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Operations Manager
2 days ago
Insight Global Los Alamitos, United StatesA top aerospace client is looking for an Operations Manager to join their team in Los Alamitos, CA. The ideal candidate will be coming from an aerospace manufacturing environment and have experience overseeing production teams. This person will be directing manufacturing and qual ...
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Operations Manager
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Eleven Recruiting Los Alamitos, United States*Summary:* · Responsible for the overall execution of the manufacturing plan. Works with clients and internal resources to provide the fabrication and delivery of products. Manages a team of supervisors to guarantee product fabrication and delivery. · *Essential Duties and Resp ...
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Operations Manager
1 week ago
Horizon Dynamics New Richland, United StatesThe transportation industry is the backbone of modern society. Can you imagine using your expertise to create sustainable transportation solutions for the future? If you want to make a global impact by working with cutting-edge technology and the best teams, then you could be a p ...
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Food & Beverage Operations Manager
6 days ago
ASM Global Long Beach, United StatesPosition: Food & Beverage Operations Manager · Department: Food & Beverage · Location: Long Beach Convention and Entertainment Center, managed by ASM Global · Reports To: Food & Beverage Operations Director · FLSA Status: Salaried, Exempt · Rate: $70K-$80K · Summary: Join t ...
Regulatory Submissions Management and Operations - Signal Hill, United States - Sapta Global Inc
Description
Job Description
Job DescriptionJob Title:Regulatory Affairs AnalystLocation: 1125 Trenton-Harbourton Rd, Titusville, NJ Route 202 South, Raritan, NJ 08869, RemoteDuration: 12 MonthsSalary: $ 45/hr.
(all inclusive)Job Type:
W2, Temporary, Contract, Corp-Corp
Work Schedule:
Mon-Fri 40 hrs.
work weekDeliverables to be performed:
