- Danaher Corporation (Boston, MA)
- …510k and PMA in USA) and will mentor the organization in these key activities. The Senior Principal Regulatory Affairs will work with Biopharma partners ... Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal , Regulatory Affairs … more
- Bausch + Lomb (Boston, MA)
- …Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to ... + Strong business acumen and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative ideas to promote a successful… more
- Bausch + Lomb (Boston, MA)
- …degree or equivalent; Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, ... Strong business acumen and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative ideas to promote a successful … more
- Merck (Boston, MA)
- **Job Description** ** Senior Principal Scientist Translational Medicine, Immunology** Translational Medicine in our Research & Development Division is ... Immunology Therapeutic Area Lead in Translational Medicine. **Primary responsibilities for the Senior Principal Scientist include the following:** + Key member… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Senior Director (Sr. Principal Scientist) has...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …primary reporting contact for the Institutional IND portfolio managed by the CTO Regulatory Affairs Core. The Institutional IND RC centrally prepares, submits, ... Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly...As necessary, the Institutional IND RC assists the CTO Regulatory Affairs Core with other required hard… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and … more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The Senior Director (Sr. Principal Scientist) has...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- ConvaTec (Lexington, MA)
- …compliance with all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Convatec's policies and SOPs. **Key Responsibilities:** + ... input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as… more
- Fresenius Medical Center (Waltham, MA)
- …and Capacity Planning, Materials Management, Distribution, Finance, Quality Systems and Regulatory Affairs , and integrated business units such as Sales ... philosophy. Adheres to the FME Compliance Program, including following all regulatory and division/company policy requirements. Manage the SC Program Management… more