Senior Vice President, Regulatory Affairs - Boston

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 ...

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. · ...

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

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 Director 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. · ...

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 ...

Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. · ...

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 ...

The Regulatory Affairs Director 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. · ...

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 ...

We are seeking a Regulatory Affairs Specialist to join our Global Regulatory Affairs Team. The ideal candidate will have experience in regulatory affairs and a passion for driving innovative solutions. · ...

We believe there is a smarter, more data-driven way to make decisions in healthcare and our cloud-native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis.You will have direct input to our mission to democratize data-driven medicine for the ultimate bene ...

Analyze regulatory activities related to medical devices and in vitro diagnostic products for US and international regions. · Responsibilities include product development, manufacturing and distribution compliance with applicable regional regulations.This includes supporting comp ...

We are seeking an experienced Regulatory Consultant to independently lead regulatory projects and deliver high-quality, pragmatic regulatory advice to clients across the US, EU, and UK regulatory landscapes.The opportunity involves leading smaller regulatory projects end-to-end a ...

The Head of Regulatory Affairs will take full ownership of the end-to-end registration and filing process for innovative drugs in the U.S. market. · A Master's degree or above in Pharmacy, Biomedical Sciences, Clinical Pharmacy or related fields; · No less than 8 years of experie ...

The Head of Regulatory Affairs is responsible for leading the registration and filing process for innovative drugs in the U.S. market. · ...

The Regulatory Affairs Coordinator is responsible for supporting the creation and maintenance of labelling projects to enable worldwide regulatory submissions. They prepare and maintain tracking sheets, coordinate the delivery of compliant documentation, and guide experts with re ...

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 ...

We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Join us in our mission to improve the human condition across multiple diseases. · Provide support for product development, manufacturing ...

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 and ensure that there is a sound regulatory foundation for the successful advancement of the products through d ...