- Cardinal Health (Boston, MA)
- **What Regulatory Submissions Operations contributes to Cardinal Health** Regulatory provides regulatory affairs and product development consulting ... subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. … more
- Medtronic (Boston, MA)
- …to innovation in a more connected, compassionate world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key role in ... regulatory activities throughout the product lifecycle. The senior principal specialist has primary responsibility for...the international regulatory affairs group to support regulatory submissions worldwide for Class II medical… more
- Bayer (Cambridge, MA)
- …facilitate improved collaboration. **Lead the preparation and/or review of IVD/CDx regulatory submissions (SRD, 510(k), IDE, PMA/CE-marking) to support clinical ... to make a real difference, there's only one choice.** ** Senior Director, Global Regulatory Leader-IVD** The ...In Vitro Diagnostics is required; + Solid experience leading regulatory submissions for IVD/CDx, including for use… more
- Merck (Cambridge, MA)
- …(GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions . The candidate will play a key role in ... ability to influence scientists to adapt to positive change. * Experience with regulatory submissions and understanding of the review process. * Familiarity with… more
- Middlesex Savings (Natick, MA)
- …management reports including borrowing base reports that govern lines of credit, regulatory compliance reports, and sales and sales activity reports. Maintains and ... + Assists loan officers and the Credit Department in preparation of loan submissions including but not limited to credit analyses and loan approval requests,… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Senior Clinical Research Director **Location:** Cambridge, MA **About the Job** **About the job** Are you ready to shape the future of medicine? The ... in helping our teams accelerate progress. Join our Fitusiran Clinical Team as Senior Clinical Research Director and you will be the primary Clinical Lead for… more
- Sanofi Group (Cambridge, MA)
- …structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications ... you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is noted as...for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the… more
- Beth Israel Lahey Health (Boston, MA)
- **Overview** **The Senior Research Administrator, Post-Award (Research Administrator II)** will, under the direction of the Director, Major Projects and Post Award ... and translate financial data so it is understandable for the non- specialist . Investigate any anomalies and provides timely resolutions. Reallocate budgets and… more