The Department of Urology is seeking to hire a full time Clinical Trails Regulatory Coordinator to be responsible for regulatory coordination of clinical research studies within assigned units at the Institute of Urologic Oncology. Main responsibilities include Performing detailed review of clinical research protocols and utilizing that information to prepare, manage and

Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

The County of Santa Cruz offers a generous benefits package which includes annual leave, paid holidays, medical, dental, vision and CalPERS retirement benefits! The County of Santa Cruz has an exciting opportunity for an Analyst to join the Employment Services team (aka Recruiting Division) in the Personnel Department. Recruiting Analyst Position The Recruiting Analyst fo

James Hardie Building Products Inc. is the North American leader in fiber cement home siding and exterior design solutions. Hardie products offer long lasting beauty and endless design possibilities with trusted protection and low maintenance. The company pioneered modern fiber cement building products and continues to invest in innovation to transform the industry. James

The Director, Regulatory Affairs for EMEA is responsible for successful completion of complex regulatory projects, including pre submissions and IDE submissions to FDA, IRB submissions, Ethics Committee submissions, EU Annex XIV submissions and as well as premarket authorization applications, including PMAs and EU Technical Documentation submissions to the notified body a

/JOB PURPOSE Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company wide initiatives around end to end labeling and provides dedicated support on Regulatory related activities and deliverables. This role requires an e

Through the operation of the Service Center, this position will develop and maintain a ministry of service and actively promote the structure and identity of The Salvation Army and its mission. The Coordinator will manage and supervise The Salvation Army's daily social service assistance programs within their community. They will work with their Field Representative to cr

Human Resources in Public Transportation

Transportation Planning

Job Posting Equity Officer (CEA, Level A) Department of Corrections & Rehabilitation JC 427547 Equity Officer (CEA, Level A) C. E. A. $9,755.00 $11,807.00 per Month Final Filing Date 5/4/2024 Job Description and Duties The California Department of Corrections and Rehabilitation (CDCR) and California Correctional Health Care Services (CCHCS) is seeking a diversity, equity,

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life changing treatments for patients with under addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis and uterine fibroids , as

What we are looking for Desire to learn Regulatory Affairs CMC and global submission strategy Strong organizational skills with attention to detail Proficient time management skills and ability prioritize workload Ability to work both independently and as a member of a team Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project Experie