- Sanofi (Framingham, MA)
- …Auditing and Regulatory Inspections. Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical ... Auditor. Direct experience preparing for and supporting Regulatory Inspections from Regulators (eg, US FDA , ANSM, PMDA, NMPA, EMA, MHRA, etc.) Action oriented,… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …operations and remain within their validated state and regulatory compliance .. The main manufacturing systems include incubators, bioreactors, chromatography skids, ... manufacturing operations and remain within their validated state and regulatory compliance . cause unknown with no product impact) complexity. Expectation to carry… more
- 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
- Merck (Boston, MA)
- …Laboratories (Research & Development) by: + Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory ... the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance … 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
- 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
- Bristol Myers Squibb (Devens, MA)
- **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is ... their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . At **Bristol Myers Squibb** we are reimagining the future of cell… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical ... Technologies (safety databases, signal detection, case processing automation, E2B compliance ). + Ensure platforms are integrated, compliant, and user-centric across… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Good Engineering Practices (GEP), GAMP, and cGMP. + Investigate and document compliance and safety deviations, establishing root causes using advanced tools and ... in a cGMP Engineering role within pharmaceutical, biotechnology, or other FDA regulated industry. + Proficient understanding of instrumentation, and its… more
