- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, ... Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled… more
- Chiesi (Boston, MA)
- …portfolio-wide objectives. + Regulatory and Compliance: + Ensure RWE studies meet regulatory standards (eg, FDA , EMA guidelines) for use in submissions and ... innovation, empowering you to drive transformative changes that accelerate drug development and market entry on a global scale,...prefer for you to have + Experience working with regulatory agencies (eg, FDA , EMA) on RWE… more
- IQVIA (Boston, MA)
- …significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in ... and identifying new business opportunities. + Provide due diligence scientific, medical, regulatory , and drug development expertise and activities for IQVIA or… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to… more
- J&J Family of Companies (Danvers, MA)
- …risk management tools and methodologies (FMEA, FTA). + Experience supporting regulatory submissions and preparing verification packages for FDA /Notified Body ... devices. You will lead design verification activities in preparation for regulatory submissions and work closely with electrical, mechanical, software, and clinical… more
- Cytel (Boston, MA)
- …and associates across Cytel. + Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and ... junior colleagues, and driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape… more
- Takeda Pharmaceuticals (Boston, MA)
- …robustness and supply continuity. As needed, you will represent Small Molecule Drug Substance in forums with partners including Regulatory , Quality, Analytical ... reports + investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …approaches. + **Compliance & Risk Management** + Ensure all training programs meet global regulatory standards ( FDA , EMA, ICH, etc.) and internal SOPs. + Monitor ... focus on GxP compliance and training. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design… more
- Sanofi Group (Cambridge, MA)
- …and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post-marketing stages. The ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse… more
- 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