- Sanofi Group (Cambridge, MA)
- …strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research… more
- Fresenius Medical Center (Waltham, MA)
- …device sector or related industries + Several years of practical experience in FDA inspections and cooperation with US regulatory authorities (experience with ... activities are in compliance with FME policies and procedures and applicable regulatory requirements + Develop and maintain audit processes and documentation to… more
- AbbVie (Waltham, MA)
- …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...Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + ... each project. + Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence… more
- AbbVie (Waltham, MA)
- …R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. ... leaders within the R&D and corporate strategy organizations on legal and regulatory issues that impact pipeline development, government agency engagement and product… more
- Catalent Pharma Solutions (Chelsea, MA)
- …+ Participated in managing and fronting Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under ... establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements; + To ensure that the site complies with… more
- Abbott (Westford, MA)
- …and develop a high performing team. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... priority within manufacturing and that product meets all design, manufacturing, and regulatory requirements. + Ensure a safe work environment consistent with OSHA… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device Development (DPDD) group provides strategic clinical leadership ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:**… more
- Sanofi Group (Cambridge, MA)
- …and various R&D functions such as patient safety/pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...biomarkers.Cultivaterepresentation of Sanofi at key industry conferences (eg DIA, FDA industry workshop) and academic forums. + Establish and… more
- Charles River Laboratories (Shrewsbury, MA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more