Regulatory Affairs Manager: Average Salary in Boston, 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....

Prior experience must include: Vendor and Client Management for Regulatory Operations – Manage relationships with vendors and clients for various regulatory operations services; Identify and evaluate potential eCTD submission vendors based on their experience, expertise, cost-effectiveness, and trac...

Affairs, Marketed Products in Cambridge, MA to Assist the Global Regulatory Lead (GRL) and is accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissio. ...

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...

CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Global Health Authoritie. ...

Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development p...

Regulatory Affairs and Quality Assurance Manager. In this position you will: Manage and coordinate the regulatory affairs and quality assurance departments of the Company while reporting directly to the President. Cambridge Interventional is seeking a Manager of RA/QA. Prepare and submit device regu...

As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Senior Manager/Associate Director, Regulatory Strategy. Your expertise and leadership will be in...

As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy for our programs in clinical development. As the Senior Manager, Regulatory Affairs, you will be responsible for:. Support the regulato...

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 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...

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...

Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements. Communicate/liaise with clients, regulatory agencies/competent authorities...

The Senior Grants and Contracts Manager will support innovative research at the world's leading public health research institution, primarily in the Department of Global Health & Population. The Senior Grants and Contracts Manager is an integral part of the research enterprise and works in close par...

Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development 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 ...

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...

As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy for our programs in clinical development. As the Senior Manager, Regulatory Affairs, you will be responsible for:. Support the regulato...

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 Manager is a key member of the Legal, Regulatory Affairs & Compliance (LRAC) team. Regulatory Affairs Manager-(3291838). The Senior Regulatory Affairs Manager will also serve as the LRAC subject matter expert for all project implementation work associated with the assig...

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...

The successful manager will be an active member of the Regulatory Affairs leadership team and manages department activities with responsibility for results in terms of costs, timing, methods and employees. Responsible to implement policies, procedures, practices and strategies for Regulatory Affairs...

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...

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...