- Sanofi Group (Framingham, MA)
- **Job Title:** Compliance Head - US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head - US FDA **Location** ... thought was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up**… more
- Sanofi Group (Cambridge, MA)
- …in helping our teams accelerate progress. We are seeking a Principal Scientist, Lab Head to join the US -based Laboratory Sciences group within the Translational ... **Job Title:** Principal Scientist, Lab Head Quality Processes **Location:** Cambridge, MA **About the...support generation, review and reporting of high-quality data in compliance with internal quality systems and regulatory guidelines (GLP… more
- Orchard Therapeutics (Boston, MA)
- …cell and gene therapies. Orchard has its global headquarters in London and its US headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a ... Japan-based Global Specialty Pharmaceutical Company. The Head of Pharmacovigilance will be responsible for leading Pharmacovigilance for Orchard, driving patient… more
- Sanofi Group (Framingham, MA)
- …and Regulatory Inspections. + Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products ... + Direct experience preparing for and supporting Regulatory Inspections from Regulators (eg, US FDA , ANSM, PMDA, NMPA, EMA, MHRA, etc.) + Action oriented,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to the National Director, ADMs, and in Stage 2, would transition to report to the US Head of Sales. Responsibilities and Duties in Stage 1 + Contribute to ... patients and their families. Our commercial product is currently FDA -approved for two indications, and we have recently reported...to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek… more
- Takeda Pharmaceuticals (Boston, MA)
- …your career? If so, be empowered to take charge of your future at Takeda. Join us as the Executive Director of Clinical Operations reporting to the Head of ... We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to **deliver Better Health and a Brighter Future**… more
- Sanofi Group (Cambridge, MA)
- …lead for a clinical development program** , reporting into the Global Project Head (GPH), and leading a team of Clinical Research Directors and Clinical scientists. ... submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China...+ Coordinate with CRDs in the project, Global Project Head , The PV Rep, Regulatory + Provide expertise in… more
- AbbVie (Worcester, MA)
- …neuroscience, and eye care. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and ... member of the quality leadership team and reports directly to the Site Head of Quality. This role is responsible for providing strategic leadership, appropriate… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration ( US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic...electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world… more
- Sanofi Group (Cambridge, MA)
- …competitive advantage. + You may partner directly with the Global Project Head (for development) and/or Industrial Product Leader (for LCM) integrating their team ... Stay abreast of the technology and Regulatory landscape and compliance standards applicable to the global target markets of...+ Experience with regulatory agencies or notified bodies, eg, FDA , EMA or TUEV and solid knowledge of key… more