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 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 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...
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 ...
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 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...
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...
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...
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...
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...
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...
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...
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 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 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...
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...
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...
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...
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 ...
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...
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...
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...