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 ...

Site: The General Hospital Corporation · Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teach ...

Site: The General Hospital Corporation · Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teach ...

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

Director, Regulatory Affairs – Rare Disease · Boston, Massachusetts | Hybrid · Company Overview · An innovative · clinical-stage biopharmaceutical company developing genetic medicines for rare diseases · is seeking a · Director of Regulatory Affairs · to support global regulatory ...

Director, Regulatory Affairs – Rare Disease · Boston, Massachusetts | Hybrid · Company Overview · An innovative clinical-stage biopharmaceutical company developing genetic medicines for rare diseases is seeking a Director of Regulatory Affairs to support global regulatory strateg ...

About Formation Bio · Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.  · Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of c ...

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

· About Formation Bio · Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. · Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of ...

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 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. · ...

Core Responsibilities: · Take full ownership of the end-to-end registration and filing process for innovative drugs (small molecules/biologics) in the U.S. market, lead the coordination, compilation, review, and submission of IND, NDA/BLA and other filing documents, ensuring com ...

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 hands-on Director of Regulatory Affairs to lead global regulatory strategy for a Class II medical device company. This role will own 510(k) strategy, agency engagement, and submission execution in a growing, innovation-driven company. Their portfolio consists pri ...

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 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 ...

About Us · We are a fast‑growing biopharmaceutical organization advancing a pipeline of innovative therapies aimed at transforming patient lives. As our programs progress, we are expanding our Regulatory Affairs team with a strategic, detail‑oriented leader who thrives in dynamic ...

Who we are: · Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address ...

We are seeking a hands-on · Director of Regulatory Affairs · to lead global regulatory strategy for a Class II medical device company. This role will own 510(k) strategy, agency engagement, and submission execution in a growing, innovation-driven company. Their portfolio consists ...

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