Regulatory Affairs Manager: Average Salary in Newton, MA in 2024

Takeda Development Center Americas, Inc.Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics....

The Regulatory Affairs Project Manager is an experienced project manager who works closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and international health authorities. This role provide...

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...

Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills: Ability to work with firm deadlines and adapt quickly to changin...

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 Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for developmental programs. Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. T...

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...

Responsible for implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs. This position will also assist the Regulatory CMC team with special projects as assigned. Responsible for coordinating all aspects of regulatory CMC submissions relev...

The Regulatory Affairs Manager will be responsible for supporting US and International product launches and maintenance. A Manager, Design, Manufacturing, Management, Support, Technical, Engineer, International. ...

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 Regulatory Affairs Project Manager is an experienced project manager who works closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and international health authorities. This role provide...

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...

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 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...

Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA...

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...

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 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...

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 ...

Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills: Ability to work with firm deadlines and adapt quickly to changin...