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Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submission
Demonstrated expertise in FDA regulatory frameworks and evolving regulatory policy landscape. The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Company’s Endocrinology pipeline, spanning
Acord is looking for a Network Systems Engineer in San Diego to enhance the university's network infrastructure. Responsibilities include maintaining and optimizing network systems and collaborating with teams.
Sharp HealthCare in San Diego is seeking a Data Analyst to enhance internal audit and compliance initiatives through data analysis and visualization. Sharp HealthCare provides a competitive pay range and a commitment to equal opportunity employment.
About the Role Supports Clinical Operations (ClinOps) on efforts related to clinical process compliance, continuous improvement, and inspection readiness activities. Requirements BS/BA degree in life science or related field AND2+years of experience in Clinical Compliance, Clinical Operations, or re
Responsible for the strategic regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submission
The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals. Coordinate governance proc
Regulatory Affairs, Licensing and Accreditation Supports multi?hospital regulatory readiness and ongoing compliance with Joint Commission, CDPH, CMS, and other applicable regulatory and accreditation agencies. The Senior Specialist works collaboratively with operational leaders, quality, patient saf
Project Manager, Regulatory Affairs (Clinical and CMC). Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC. Proficiency in project management and regulatory systems is essential.
The Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end-to-end submission execution. This role is a key member of the Global Regulatory Affairs Lea
The Senior Director, Finance & Analytics will support financial performance, strategy, and operations. Prescient Holdings Group (PHG) is a healthcare company providing pharmaceutical management solutions to payers, patients, and providers. Responsible for oversight, and management of the strategic p
Demonstrated expertise in FDA regulatory frameworks and evolving regulatory policy landscape. The Executive Director, Regulatory Strategy Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Company's Endocrinology pipeline, spanning earl
Principal, Underwriting and Analytics. Prescient Holdings Group (PHG) is a healthcare company providing pharmaceutical management solutions to payers, patients, and providers. The Principal, Underwriting and Analytics provides expertise and leadership for all pricing and underwriting activities asso
Regulatory Affairs, Licensing and Accreditation Supports multi?hospital regulatory readiness and ongoing compliance with Joint Commission, CDPH, CMS, and other applicable regulatory and accreditation agencies. The Senior Specialist works collaboratively with operational leaders, quality, patient saf