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

Senior Manager, Regulatory Affairs - CMC. The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals. Oversee the preparation, submission, and maintenance of regulatory appl...

Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the digital transformation of next gen devices. Bachelor’s degree or higher in Science, Engineering, Re...

Minimum 7 years of regulatory affairs experience in the U. Serve as the R&D lead on all product-related regulatory matters. Collaborate with legal, product development, marketing, sales, food safety & quality, sourcing, planning, and operations to identify and address current and future regu...

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 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...

Senior Manager, Regulatory Affairs - CMC. The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals. Oversee the preparation, submission, and maintenance of regulatory appl...

Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the digital transformation of next gen devices. Bachelor’s degree or higher in Science, Engineering, Re...

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...

Join Takeda as a Manager, Global Regulatory Affairs CMC Submission Management where you will support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned products. As part of the Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC ...

Minimum 7 years of regulatory affairs experience in the U. Serve as the R&D lead on all product-related regulatory matters. Collaborate with legal, product development, marketing, sales, food safety & quality, sourcing, planning, and operations to identify and address current and future regu...

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 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...

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 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...

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 ...

Join Takeda as a Manager, Global Regulatory Affairs CMC Submission Management where you will support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned products. As part of the Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC ...

Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions. Assesses regulatory pathways for new products and product modifications; develops regulatory...

The Regulatory Affairs and Education Manager will report to the Director, Regulatory and Education Program in Clinical Research Operations (CRO). The Regulatory Affairs and Education Manager will work closely with clinical research investigators, their research teams and other BCH research programs ...

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...

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...

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...

Experience in regulatory filing project management. ...

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...

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...