- 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 ... if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical...stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work 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
- Medtronic (Boston, MA)
- …and provide guidance on promotional and advertising materials to ensure compliance with regulatory standards. + Apply in-depth knowledge of FDA regulations, EU ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...world. **A Day in the Life** As a **Principal Regulatory Affairs Specialist** at Medtronic, you will play a… more
- Philips (Cambridge, MA)
- …Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA , EU and other worldwide government ... **Senior Regulatory Affairs Specialist (Ultrasound)** The Senior Regulatory...Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate a track… more
- Sumitomo Pharma (Boston, MA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …(eg, clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Chiesi (Boston, MA)
- …Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years' experience, operating in 30 countries with ... Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
- Merck (Boston, MA)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... Experience leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated expertise in leading regulatory filings across… more
- Rhythm Pharmaceuticals (Boston, MA)
- …for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage ... to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory … more
- Nanobiosym, Inc. (Cambridge, MA)
- …federal, state, and international tax regulations while managing government contracts and healthcare -related regulatory requirements (eg, FDA , IRB approvals, ... 10+ years of legal experience (in-house and law firm), with expertise in healthcare , regulatory compliance, corporate governance, and IPO preparation. + Strong… more