- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA , EMA, PMDA) and internal standards. + ... Support internal audits and regulatory inspections, including readiness activities and remediation. + Analyze, monitor, and maintain KPIs and dashboards to identify… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role ... deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and align with current GMP ... systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement**… more
- Charles River Laboratories (Wilmington, MA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...delivery of NHPs. * Stay current on industry trends, regulatory changes, and competitor activity to inform strategy and… more
- Takeda Pharmaceuticals (Boston, MA)
- …and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine ... It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. As part of DQS, the… more
- Pfizer (Andover, MA)
- …+ Ensures that combination product development activities are compliant with quality and regulatory standards - both internal and external. + Lead design control and ... limited to human factors engineering assessments. + Support the generation of all regulatory submission data and content for assigned device projects. + Support the… more
- Fresenius Medical Center (Lawrence, MA)
- …to ensure accuracy, relevance, and alignment with treatment protocols and regulatory standards. Coordinate with Product Marketing, Value Stream, and the ... products Ensure all materials are reviewed and approved through appropriate regulatory and medical review processes. **PHYSICAL DEMANDS AND WORKING CONDITIONS:** The… more
- Abbott (Burlington, MA)
- …and other regulatory requirements + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, ... from to varied disciplines including Engineering, Marketing, Clinical Affairs, and Regulatory Affairs. + Demonstrated leadership in team settings, including the… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... variable factors which may include customer impact, HCUS business priorities and regulatory requirements. Provides to assistance to all connected teams on technical… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA , EMA, ICH). + Prepare documentation and ... outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality… more