Regulatory Affairs Manager: salario promedio en Cambridge, MA in 2024

Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset. Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strate...

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...

Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset. Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strate...

Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...

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...

The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office. The Manager/Senior Manager will also participate to formulate regulatory CMC strategies for product developmen...

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...

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...

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...

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...

Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Develops detailed regulatory project plans and lead or support regulatory activities relating to specific portfolio of prod...

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 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...

Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Collaborates with other functional work teams , Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of glob...

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...

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...

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...

Reporting to the Global Head Regulatory Affairs this position will collaborate closely with the broader regulatory & scientific affairs team. Regulatory & Scientific Affairs Manager - This position may be based in Decatur, IL; Quincy, IL; Harvard, IL; or Fort Collins, CO. Lead a team of 5 Regulatory...

The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes’ European office. The Manager/Senior Manager will also participate to formulate regulatory CMC strategies for product developmen...

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...

Program Manager, Regulatory Affairs. You will develop regulatory strategies and regulatory submissions for new and modified products to the FDA and International regulatory bodies. In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and bi...

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...

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...

The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory aff...