Senior Manager 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 ...

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

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. · ...

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. · ...

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 Director of Regulatory Affairs to lead global regulatory efforts across development programs. · ...

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 ...

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. · ...

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 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 ...

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 working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. · ...

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 ...

We are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. · 10+ years pharmaceutical/biotechnology industry experienc ...

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 ...

We are working to change the paradigm and improve the science of cancer treatment. · ...

+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 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 ...

Job summaryThe Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. · ResponsibilitiesThe Regulatory Coordinator is responsible for the coordination, preparation, and maintenance o ...

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. · ...