- Cytiva (Shrewsbury, MA)
- …responsible for providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading ... the QA Senior Manager Site Quality Leader and is part of the Quality and Regulatory Affairs Team located in Shrewsbury, MA. and will be an on-site role.What you will… more
- Cardinal Health (Boston, MA)
- …Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- ManpowerGroup (Cambridge, MA)
- Our client, a leader in the pharmaceutical industry, is seeking a Pharmaceutical QA Specialist to join their team. As a QA Specialist, you will be part of the ... collaboratively, which will align successfully in the organization. **Job Title:** Pharmaceutical QA Specialist **Location:** Cambridge, MA **Pay Range:** $50-55 per… more
- Fresenius Medical Center (Waltham, MA)
- …of a medium-sized company + Supporting the department in cross-site activities to monitor product quality and regulatory compliance **EOE, disability/veterans** ... - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory expert development and new registration projects (Medicinal Products) +… more
- Fresenius Medical Center (Waltham, MA)
- …the global development and commercialization of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA, EMA, ... AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays… more
- Sanofi Group (Cambridge, MA)
- …background in cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The ... between validated and non-validated systems, ensuring data flows smoothly while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work… more
- Sanofi Group (Cambridge, MA)
- …background in cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The ... between validated and non-validated systems, ensuring data flows smoothly while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary ... all CMC and GMP related documents for submission to regulatory authorities to assure compliance with ...programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance . Ability to draw from ... and efficiencies. + As a GRA CMC member, ensures and / or enhances regulatory compliance . + Ensures project team colleagues, line management, and key… more
- Grifols Shared Services North America, Inc (Fall River, MA)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
