- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA) and internal standards. + Support… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …actions (CAPAs). + **Stakeholder Engagement** : Collaborate with Clinical Operations, Regulatory Affairs , Pharmacovigilance, and other functions to ensure ... of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member of the Global Quality… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …+ Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs , and technical operations to ensure alignment ... systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement**… more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong… more
- Unilever (Boston, MA)
- …lead teams in identifying alternatives or design adjustments. + Partner with Regulatory Affairs to guarantee accurate monitoring and documentation of essential ... development process. + Partner with R&D, Supply Chain, Operations, Quality, Regulatory , Procurement, and external vendors to deliver packaging from concept through… more
- Takeda Pharmaceuticals (Boston, MA)
- …work allowed from anywhere in the US **REQUIREMENTS:** Bachelor's degree in Pharmacy, Regulatory Affairs , Clinical or related field plus 5 years of related ... documentation, vendors, and internal systems to ensure adherence to GCP, regulatory requirements, and internal policies; assess audit findings and compliance risks,… more
- Fallon Health (Worcester, MA)
- …and external customers. Interacts with departments such as Accounting, Sales, and Regulatory Affairs . Maintains a positive approach to issues and concerns ... Supplement, NaviCare, Summit Elder Care, Fallon Health Weinberg and any future regulatory products is entered into Fallon Health's core system. Completes work… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the… more
- Sumitomo Pharma (Marlborough, MA)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health.… more
- Hologic (Marlborough, MA)
- …compliance. + Collaborative and team-oriented, building strong relationships across R&D, Regulatory Affairs , Manufacturing, and other key stakeholders. + ... new product development, ensuring that design controls, risk management, and global regulatory compliance are maintained from concept to product launch. In this… more