Avantor, a Global Fortune 500 company is looking for a dedicated Regulatory Specialist to optimize our Avantor Fluid Handling (AFH) organization. As a Regulatory Specialist- Licensing, you will be responsible for collaboratively:. If you have regulatory experience - let's talk!. Preparing/ directing...
The Recall Regulatory Specialist III will be responsible for leading OUS (outside the US) field action execution activities including managing Field Action Strategy Team meetings, coordinating and preparing document packages to notify regulatory agencies of field action activities, drafting internal...
Managing Consultant, Environmental Regulatory Specialist (Senior Level). Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (...
The Corporate Information Services Department is seeking a dynamic and talented Senior Clinical Informatics Specialist. The Senior Clinical Informatics Specialist provides guidance in identifying, developing, implementing, and maintaining an efficient and effective clinical information system. ...
This position has several primary functions and/or responsibilities:1) Responsible for developing and executing process validation protocol for aNDA product.Perform quality control testing and production of aNDA products and become subject matter expert in aNDA product.Initiate investigation in prob...
Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the NCI/NCTN Senior Regulatory Affairs Study Start-Up Specialist will prepare and process, independently all initial oversight submissions regulatory documentation through the Penn IRB/CIRB, CTSRMC, and all applicable regulat...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing review...
This Senior Specialist, Regulatory Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West’s global portfolio of medical devices, combination products, SaMDs, and packaging components. Collaborate with regulatory lead(s), cross-functional proje...
Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the NCI/NCTN Senior Regulatory Affairs Study Start-Up Specialist will prepare and process, independently all initial oversight submissions regulatory documentation through the Penn IRB/CIRB, CTSRMC, and all applicable regulat...
As a Regulatory Risk Specialist within PNC Investments organization, you will be based in Philadelphia, PA or Bridgewater, NJ. Partners with regulatory risk manager to execute regulatory risk initiatives including setting up, building and monitoring initiatives. Participates in regulatory and audit ...
Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing review...
The Corporate Information Services Department is seeking a dynamic and talented Senior Clinical Informatics Specialist. Senior Clinical Informatics Specialist. ...
This position has several primary functions and/or responsibilities:1) Responsible for developing and executing process validation protocol for aNDA product.Perform quality control testing and production of aNDA products and become subject matter expert in aNDA product.Initiate investigation in prob...
We are recruiting for a French Speaking Senior Regulatory Affairs Associate in Europe. Senior Regulatory Affairs Associate- CTA. Previous CRO / Pharma experience working in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant with CTA submission knowledge is essent...
As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. ...
The Regulatory Affairs Manager works within a team environment or individually based on the project needs, such as:. Interested candidates in the Regulatory Line Manager from Mexico, DC (at least 3 or 4 years of experience) leading large teams. The Manager within R&A provides leadership and directio...
Senior Regulatory Affairs Associate. Assessment of the Change Controls and associated technical dossiers. ...
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across diff...
Quality Assurance / Regulatory Affairs Manager. The QA/RA Manager (Quality Assurance / Regulatory Affairs) is responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS). The QA/RA Manager is responsible for global regulatory affairs and...
Monitor employee electronic communications to maintain compliance and protect the integrity of our operations. Maintain and organize the firm’s compliance calendar, regulatory books, and records, ensuring everything is up-to-date and in order. Coordinate and track service provider compliance with ou...
The Associate Director – CMC Regulatory is responsible for leading global CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC regulatory impact of change ...
We are seeking a Medical Quality Assurance (QA) Specialist to support our Veteran Affairs Operations in Malvern, PA. To provide high-quality, timely, and customer-focused medical examination service solutions, we honor our core values of integrity, innovation, agility, collaboration, inclusion and c...
The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities. The position is responsible for providing daily Quality As...
Manage ongoing program needs and suggest program improvements to further enhance learning program effectiveness and sustainability within Transformational Capabilities capability. Our prestigious, well respected client is seeking a L&D Program Manager, Content Transformation to complement their expa...