Team 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. · ...

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 ...

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. · ...

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 ...

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

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 ...

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. · ...

The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations. · Cross-functional Collaboration: Collaborate with R&D PPM (product and project manager ...

+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 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 ...

+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 Manger of Regulatory Affairs is responsible for managing the regulatory and scientific aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies. · Identifies, obtains, compiles, authors and reviews regulat ...

The Regulatory Affairs Specialist supports the activities of the Regulatory Affairs Department in ensuring compliance with accreditation, licensing, and regulatory requirements. · This position assists with survey readiness, documentation management, · performance tracking, · and ...

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 ...

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 ...

In this role you 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. · ...

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. · ...

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

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

We are looking for a Regulatory Affairs Specialist to develop and deploy innovative and compliant regulatory strategies across business and markets. · Assist in implementing comprehensive regulatory strategies by collaborating with regulatory subject matter experts (SMEs). · Coor ...