- Dana-Farber Cancer Institute (Brookline, MA)
- …documents for SRC and IRB review and approval + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares,… more
- Philips (Cambridge, MA)
- …new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... reviewed with the RA management. + Driving improvement in regulatory aspects of the Quality Management System...if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical… more
- Cole-Parmer (Franklin, MA)
- Job Title: Sr. Manager, Quality and Regulatory Assurance Reports To: VP, Quality Position Location: Franklin, MA FLSA Status (Exempt/Non-Exempt): FLSA ... Status: Exempt Position Summary: The Senior Manager, Quality and Regulatory Assurance position is responsible...IVDD and IVDR compliance and regulations\ + Experience with FDA 21 CFR Part 820 regulations + Minimum of… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- Fresenius Medical Center (Waltham, MA)
- …high- quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... commercialization of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- United Therapeutics (Boston, MA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of eCTD submission-ready documents, coordinating across functions, and ensuring quality , accuracy, and adherence to regulatory guidelines. Additionally, ... (SOPs) quality assurance, and records management practices related to regulatory operations activities + Track regulatory department information such as… more
- Merck (Boston, MA)
- …+ Oversee and independently lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all ... documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written communications. +… more
- Fresenius Medical Center (Lexington, MA)
- …documentation for EU Notified Body submissions; * Working with ISO13485 and FDA Quality Management System requirements (QSR); * Participating in Internal ... international markets for NxStage Medical, Inc. products. Will provide regulatory input into key quality system processes...products. Will provide regulatory input into key quality system processes such as Design Reviews and Engineering… more