Delivery lead—Regulatory affairs - Bridgewater

As a Regulatory Affairs Specialist at Mass General Brigham, you will be responsible for ensuring compliance with regulatory requirements and maintaining an updated library of FDA regulations and guidance documents. · AUTHORS AND REVIEWS OF STANDARD OPERATING PROCEDURES,T techNICA ...

Ensure compliance to FDA and other applicable regulations as Regulatory Affairs Manager. · ...

The Global Regulatory Affairs Device Lead will drive global regulatory strategies for medical device and combination products.We are seeking an experienced Regulatory Affairs professional with familiarity with international submissions from within a global healthcare organization ...

The Regulatory Affairs Manager reports to the Director of Regulatory Affairs and is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth's product and product dev ...

The Regulatory Affairs Manager is responsible for executing regulatory strategies and ensuring compliance with global regulations. They will lead the process to obtain and maintain market approval for DeepHealth's product and product development. · Oversee the day-to-day function ...

Monte Rosa Therapeutics seeks an experienced Director of Regulatory Affairs to lead global regulatory efforts across development programs in immunology. · ...

This position involves regulatory affairs with Technical Files or equivalent in an R&D or quality position with hands-on experience in the preparation review and/or auditing of medical device DHFs Risk Management files and/or DMRs. · Must have knowledge of European/International ...

Reporting to the Head of Quality, Regulatory, and Compliance, · the Director of Regulatory Affairs is responsible for executing regulatory strategies, · ensuring compliance with global regulations and leading the process to obtain · and maintain market approval for DeepHealth's p ...

Beam is seeking a Manager Regulatory Affairs to progress a broad portfolio of advanced genetic medicines in a fast paced and dynamic biotech environment. · ...

Monte Rosa Therapeutics is seeking an experienced Director of Regulatory Affairs to lead global regulatory efforts across development programs. · ...

This job involves preparing regulatory submissions while ensuring compliance with current regulations. The specialist will maintain meticulous regulatory documentation. · Proficiency in Regulatory Documentation. · Strong understanding of Regulatory Compliance. · ...

+Job Summary · The VP of Regulatory Affairs will lead create and drive the regulatory strategy for life cycle management activities for Vafseo Auryxia and early development programs. · ...

The Director, · Regulatory Affairs will lead global · regulatory strategy for development-stage · neuroscience programs. · <li_annual bonus opportunity medical dental vision life and AD&D short term long term disability 401(K) plan with match stock options flexible non-accrual pa ...

We are seeking an experienced Regulatory Affairs leader to define regulatory strategy and lead IND execution for complex oncology assets. · A Boston-based, clinical-stage biotechnology company is developing next-generation precision oncology therapies. · This role is ideal for a ...

The Regulatory Affairs Manager is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth's product and product development. · ...

Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North America. Provide collaborative support for execution of global strategies to other region ...

We are looking for a Regulatory Affairs Specialist to join our team in Cambridge, MA. In this role you will assist in implementing comprehensive regulatory strategies by collaborating with regulatory subject matter experts (SMEs) to ensure alignment with company objectives and co ...

+Be part of a Regulatory Affairs Team to develop and deploy innovative and compliant regulatory strategies across business and markets to achieve the highest standards for patient safety and product efficacy.+Assist in the implementation of comprehensive regulatory strategies by ...

The Director, Regulatory Affairs will be responsible for the strategic leadership, · development and execution of science-based, solution-oriented, · and globally aligned regulatory strategies for the program(s) · under his/her accountability.This role serves as a key · regulator ...

Job summary · Regulatory Affairs Manager for medical devices company. · Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies. · Provide regulatory guidance during product development to ensure compliance. · ...

Parexel International LLC seeks a Regulatory Affairs Consultant to prepare clinical and regulatory documentation for clinical trials. The position may telecommute from anywhere in the United States up to 5 days per week. · ...