The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes. Regulatory Affairs Program Manag...
The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. The Global Publishing Manager provides regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence i...
The Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for commercial programs. Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. The ...
Lead the global Regulatory Affairs (RA) team and provide organizational guidance and support to Thermo Fisher Scientific's Laboratory Plastic Essential (LPE) business within the Laboratory Product Group (LPG). Reporting to the Senior Director of Regulatory Affairs, the incumbent will serve as a memb...
Responsible for working with a cross-functional collaborative team to assist in regulatory strategies and initiatives for assigned programs and assist in the effective management and timely execution of regulatory filings, maintain compliance with global regulatory standards and commitments, provide...
Responsible for working with a cross-functional collaborative team to assist in regulatory strategies and initiatives for assigned programs and assist in the effective management and timely execution of regulatory filings, maintain compliance with global regulatory standards and commitments, provide...
The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process for FMI products. Advanced Degree (Master's or Doctorate) in science, engineering, regulatory a...
They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Reporting into the Senior Director of Regulatory and Clinical Operations, you will be responsible for the development and management of regulatory a...
Senior Manager, Regulatory Affairs (Clinical). Senior Manager, Regulatory Affairs. The Senior Manager will provide regulatory support for clinical studies (as assigned) with the objective to obtain regulatory approvals for the initiation of clinical studies, as well as any amendments and maintenance...
The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. Interface with regulatory authoriti...
We are seeking a Senior Manager, Regulatory Affairs to join our team. The Senior Manager will provide regulatory support for clinical studies (as assigned) with the objective to obtain regulatory approvals for the initiation of clinical studies, as well as any amendments and maintenance activities f...
Senior Manager of Regulatory Affairs and Quality Assurance - (Medical Device) - Hybrid in MA. Our client is a growing boutique IVD and Medical Device company and they are seeking a Senior Manager of Regulatory Affairs and Quality Assurance to lead a small international team to ensure compliance with...
Actively participate in problem solving discussions and recommend solutions • Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies • Assist in the maintenance and improvement of regulatory SOPs • Interact and negoti...
The Senior Manager Regulatory Affairs will play a critical role within Philips’ Clinical Informatics organization by leading regulatory projects for Philips’ Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the l...
Manager, Regulatory Affairs Labeling – Permanent – Georgia, North Carolina or Massachusetts. Proclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company with locations in Georgia, North Carolina and Massachusetts. The Manager, Regulatory Affairs Labeli...
Supports the University’s regulatory and policy work at the state level and in Harvard’s host communities, including Cambridge and Boston. Establishes and maintains an internal network of colleagues across campus to analyze, interpret, and translate opportunities, risks, and questions associated wit...
The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration a...
Regulatory Affairs Manager III. This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submissi...
The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process for FMI products. Advanced Degree (Master's or Doctorate) in science, engineering, regulatory a...
The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations, and p...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects. Responsible to communicate new regulatory guidelines. Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update ...
Regulatory Affairs Manager III. This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submissi...
The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. Interface with regulatory authoriti...
The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips’ Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes. Regulatory Affairs Program Manag...