- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding… more
- Dana-Farber Cancer Institute (Boston, MA)
- …regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ... institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works… more
- Sanofi Group (Cambridge, MA)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion ... promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable. + Provides US RA AdPromo strategic guidance and… more
- Chiesi (Boston, MA)
- …care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social ... many other enriching diversities. Chiesi USA Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent… more
- AbbVie (Waltham, MA)
- …are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. ... Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …and QA activities for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements ( FDA , EMA, etc.). ... for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This role requires a minimum… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + Ensures ... of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports… more
- Curia (Hopkinton, MA)
- …related field and a minimum of 5 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in a leadership role OR ... and activities in the manufacturing facility to ensure continual compliance with cGMP. This position requires expertise in all...of 3 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2… more
- Cambrex High Point (Waltham, MA)
- …a PhD with 1+ years of experience in analytical chemistry within the pharmaceutical industry. The candidate should have a broad experience of method development of ... TGA, DSC, particle size analyzer etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience in quality… more
- Sanofi Group (Cambridge, MA)
- …including email monitoring, live monitoring activities, and other projects in compliance with pharmaceutical industry regulations and company policies. As ... Excel and PowerPoint + Knowledge of key regulatory framework relevant to pharmaceutical email communications (eg, HIPAA, GDPR, FDA regulations, PhRMA Code)… more