Jr. Publisher – 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 ...

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 ...

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 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 ...

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. · ...

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. · ...

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. · ...

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 ...

The Regulatory Affairs Director will lead regulatory strategies for DeepHealth’s product development and commercialization.The position requires experience in regulated industries with knowledge of FDA Quality System Regulations and medical devices regulations. · Help develop glo ...

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 ...

+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. · ...

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 ...

+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 ...

We are seeking a Regulatory Affairs Consultant to prepare clinical and regulatory documentation for clinical trials and deliver consulting services to ensure that the company meets regulatory requirements. · ...

The Director, Regulatory Affairs for U.S. Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas to healthcare pr ...

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 ...

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 ...

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 ...

We are seeking an experienced Regulatory Affairs Director to join our team at DeepHealth. The successful candidate will be responsible for executing regulatory strategies and ensuring compliance with global regulations. This role involves leading the process to obtain and maintai ...