Associate I/II, Regulatory Operations - San Diego

ecoATM is a technology company that enables people to join the mobile device re-use revolution through its 7,000 automated kiosks and online marketplace. · The Regulatory Operations Coordinator performs administrative tasks to support the Legal - Regulatory Operations team in ens ...

Manage regulatory submission planning, publishing, and execution for global regulatory filings. · Manage regulatory submission planning, publishing, and execution for global regulatory filings. · Support regulatory operations infrastructure. · ...

The Associate I/II Regulatory Operations will provide essential regulatory operations document management support across Capricor development potential commercial programs. · This role tracks regulatory deliverables maintains document repositories archives assisting with submissi ...

The Associate I/II will provide essential regulatory operations and document management support across Capricor's development and potential commercial programs. · Track regulatory deliverables... · ...

The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera.This position involves planning, preparing, authoring and/or reviewing documents for inclusion in regulatory submissions, · including medical w ...

+The Vice President of Regulatory Affairs will serve as a key strategic leader overseeing global regulatory planning and execution for development programs. · +Advanced degree in a scientific or medical field (e.g., PharmD, PhD, MD, MS) · 10+ years of experience within biotechnol ...

The Program Manager – Privacy Regulatory & Compliance supports the continued improvement, expansion, and maturation of the Company's global privacy regulatory and compliance program. · ...

The Director of Regulatory CMC will lead strategic regulatory compliance for assigned commercial products and development projects to ensure timely and efficient preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions. · ...

Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems. · ...

The Regulatory Compliance Officer (RCO) plays a vital role in ensuring that operations comply with complex environmental regulations at the local, state, and federal levels. This position is responsible for leading environmental permitting, reporting, compliance tracking, and ris ...

The Senior Director Medical Writing will work with cross-functional teams to develop write and review clinical and regulatory documents ensuring the documents are of high quality and comply with internal external standards. · This position reports to the SVP Regulatory Affairs & ...

+We are seeking an experienced Clinical Trials Manager to lead and execute clinical studies within the in-vitro diagnostics (IVD) space. · +Provide clinical study status updates to leadership, including timelines, budgets, monitoring activities, deviations, and corrective actions ...

The Head of Software Engineering will define and execute the organization's software strategy supporting clinical diagnostic and commercial platforms This leader will build and scale high performing teams while ensuring delivery of secure high quality and compliant software syste ...

This role provides senior scientific and operational leadership for drug metabolism and nonclinical research capabilities in the United States.The position is accountable for shaping scientific direction, ensuring regulatory readiness, and expanding in vitro and in vivo service o ...

The organization is seeking a senior physician leader with extensive experience in obesity and cardiometabolic drug development to establish and lead clinical strategy across its therapeutic pipeline. · Clinical Strategy & Portfolio Leadership: · Clinical Program Oversight: · Reg ...

Under the direction of the Transplant Administrative Directors and in close collaboration with Medical and Surgical Directors, the Organ Transplant Program Manager provides strategic clinical and operational leadership for the transplant program optimizing patient outcomes to dri ...

We are seeking a highly experienced and forward-thinking Principal Toxicologist to join our scientific leadership team. This individual will play a central role in guiding BioLegacy's preclinical toxicology programs, · The ideal candidate brings extensive hands-on Study Director ...

The Director/Senior Director, Regulatory Affairs will lead regulatory strategy and execution for our lead program as it advances toward NDA submission and review. · The Director will serve as the primary FDA interface · This role offers a unique opportunity to shape regulatory di ...

The Regulatory Affairs Manager will support the preparation, review and submission of regulatory documentation for medical device products ensuring compliance with applicable regulations including FDA ISO 13485 and other global standards This position collaborates with cross func ...