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ORIC Pharmaceuticals is seeking a Director/Associate Director in Regulatory Affairs to support clinical development of oncology products. The successful candidate will support regulatory submissions, collaborate across functions, and ensure compliance with regulatory requirements. This role requires
Knowledgeable in global regulatory requirements and guidelines (eg, FDA guidance, ICH) and gathering regulatory intelligence. Coordinate and collaborate regulatory activities across functions within ORIC, ie, regulatory operations, quality, CMC, nonclinical, clinical. Lead to deliver high quality an
The Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross-functional development and execution of global regulatory labeling strategy. Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsisten
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. Support Global Regulatory
Ensure continued regulatory compliance of products through adherence to the change control procedures, regulatory information management procedures and completion of regulatory impact assessments for assigned commercial and development products. The Senior Manager, Regulatory Affairs Global CMC will
Senior Medical Affairs Operations Manager page is loaded## Senior Medical Affairs Operations Managerremote type:. Position Summary:**The Senior Medical Affairs Operations Manager is responsible for managing the execution of medical affairs operations, investigator initiated clinical studies, post-ma
The Senior Specialist works collaboratively with operational leaders, quality, patient safety, risk management, and system partners to support improved clinical outcomes, operational performance, regulatory compliance, and patient safety. Regulatory Affairs, Licensing and Accreditation Supports mult
The ideal candidate has 10 years of experience in Regulatory Affairs within the biopharmaceutical industry, including supervisory roles. A biopharmaceutical company in San Diego seeks an Associate Director, Regulatory Affairs CMC. This role focuses on regulatory strategy execution for drug developme
Associate Director, Regulatory Affairs CMC page is loaded## Associate Director, Regulatory Affairs CMCremote type:. Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission. Works closely with the Senior
MedImpact Healthcare Systems, Inc. Responsibilities include implementing clinical programs, analyzing data, and ensuring satisfaction for healthcare clients. The role involves managing strategic client relationships, particularly in Medicare Part D.
A leading pharmaceutical company is seeking a Senior Medical Affairs Operations Manager to oversee the execution of clinical studies and manage the medical affairs operation. The role requires managing clinical protocols, leading teams, and ensuring compliance with regulatory standards.
Ensures compliance with applicable regulatory requirements and internal procedures while supporting the overall strategy, quality, and efficiency of the Patient Safety and Pharmacovigilance function. Plays a key lead role in overseeing the multidisciplinary arena of Patient Safety Operations (clinic
Neighborhood Healthcare in Escondido is seeking a Risk Manager to promote risk management and patient safety across the organization. This role offers the chance to work in a community health setting and make a significant impact on patient safety and risk exposure.
Design, develops, and enculturates innovative ways to transform nursing care delivery and patient care systems Serves as the professional practice resource for the Patient Care leadership and Shared Governance councils, supporting the integration of professional practice standards into performance i
The Senior Specialist works collaboratively with operational leaders, quality, patient safety, risk management, and system partners to support improved clinical outcomes, operational performance, regulatory compliance, and patient safety. Regulatory Affairs, Licensing and Accreditation Supports mult
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