Regulatory Affairs Specialist III

This position plays a critical role in ensuring compliance with regulatory requirements and guidelines. The ideal candidate will have a strong understanding of regulatory affairs, excellent analytical and problem-solving skills, and the ability to communicate effectively with various stakeholders.Key ResponsibilitiesManage the submission process, including...

Job DescriptionThe Quality Assurance Regulatory Affairs Supervisor is a critical role that supports the electronic publishing of regulatory submissions for national and regional regulatory agencies, and partner companies. This position requires moderate to complex regulatory submissions in both eCTD and non-eCTD format.Key Responsibilities:Obtain...

Role OverviewThe Quality Assurance-Compliance Specialist III-Audit and Inspection is responsible for supporting all associated responsibilities in compliance with quality policies and site SOPs. This position requires a strong understanding of GMP regulations and the ability to apply this knowledge to support business growth and maintenance of inspection...

Job TitleA Regulatory Affairs Regulatory Compliance and Quality Assurance Supervisor role is available.About the PositionThe primary responsibility of this position is to support the electronic publishing of regulatory submissions for national and regional regulatory agencies, and partner companies.Key ResponsibilitiesObtain data/documents from multiple...

Job OverviewThe Quality Assurance-Compliance Specialist III-Audit and Inspection role is a pivotal position that plays a crucial part in ensuring the organization's compliance with quality policies, site SOPs, and regulatory requirements.Key Responsibilities:Collaborate with site management to foster a 'Quality Culture' by coaching employees on GMP...

Job Summary:">We are seeking a highly skilled Validation Specialist III to draft and execute validation protocols for Facilities, Utilities, Systems, and Equipment (FUSE).">Key Responsibilities:">Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure.Plan and organize validation activities amongst...

We are seeking a detail-oriented Quality Control Stability Coordinator III to join our team at FUJIFILM Holdings America Corporation.About the Role:The Quality Control Stability Coordinator III will be responsible for implementing and overseeing the Quality Control Stability Program, ensuring that all testing is conducted within specified windows and...

Job SummaryThe Quality Assurance-Compliance Specialist III-Audit and Inspection plays a critical role in ensuring the quality and integrity of our products and processes. This position requires a strong understanding of GMP regulations and the ability to apply this knowledge to support business growth and maintenance of inspection readiness.Essential...

Job DescriptionThe Director of Quality Systems will develop, implement, and maintain individual sub-systems of the Pharmaceutical Quality Systems (PQS) to meet FDBT's needs. This role requires expertise in one or more PQS sub-systems: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.Responsibilities:Establish governance...

Position OverviewSummary: Under supervision of the Supervisor, Logistics Specialist III is responsible for the assurance of accurate receipt, verification, record keeping, distribution, and shipment of materials and goods.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented...