Pharmaceutical Regulatory Affairs Jobs in Irvine

Health Sciences Counsel The candidate reports administratively to the Chief Health Sciences Counsel, as a member of the Office of Campus Counsel, to the Chief Campus Counsel, irm and, as a ..

... compliance with applicable clinical and regulatory standards and in alignment with ... project teams, development, and government regulatory agencies. Monitors and/or interprets results ... in accordance with institutional, GCP,..

Essential Functions:Evaluates event(s) to determine if it qualifies as a complaint.Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed.Manages customer relationship ..

... information, visit www.AllerganAesthetics.com.The Sr. Manager Regulatory Affairs represents US Regulatory Affairs for pharmaceutical development projects and marketed products. ... development and communication of global regulatory strategy on R&D project..

The RA/QA Intern will work closely with Quality Assurance and Regulatory Affairs to implement processes to improve quality. Responsibilities:Understanding the Quality Assurance process and helping the RA/QA team in implementing the ..

Essential Functions: Defines and conveys product vision to team(s) in order to address product requirements to ensure a successful product based on business value. Manages process improvement projects including but not ..

... chemistry aspects of the active pharmaceutical ingredient (API) and regulated starting ... for the API & RSM pharmaceutical drug substance process development, the ... clinical development programs.Collaborates closely with..

REGULATORY AFFAIRS MANAGER - PRODUCT LABELING In ... That Change Lives As the Regulatory Affairs Manager for Product Labeling, you ... will direct a team of Regulatory professionals. **A Day..

Essential Functions:Defines and conveys product vision to team(s) in order to address product requirements to ensure a successful product based on business value.Manages process improvement projects including but not limited to ..

... programs, designing clinical strategy for regulatory approvals and market access for ... will be responsible for determining regulatory needs for clinical data to ... clinical studies and for the..

Associate Counsel III The candidate will be responsible for: Provide valued, strategic, and practical legal services and solutions to PSJH with exceptional responsiveness and stewardship to all areas of PSJH with ..

**Careers that Change Lives** Medtronics Neurovascular (NV) business is focused on preventing and treating stroke a condition that will occur within 14 million people in 2021. Our purpose in NV is ..

... compliance with applicable clinical and regulatory standards and in alignment with ... project teams, development, and government regulatory agencies. Monitors and/or interprets results ... in accordance with institutional, GCP,..

... as other departments such as Regulatory Affairs and Medical Affairs. Serves as functional representative on ... in a medical device or pharmaceutical company or related setting with ... candidate..

**Engineering Program Manager Post Market Quality** **Santa Ana, CA** **Careers That Change Lives** In this exciting role you will support the Medtronic mission for unsurpassed quality and reliability in our medical ..

Senior Manager, Regulatory Affairs The candidate will be responsible ... global filing activities from a regulatory standpoint from initial product concept ... of the device/combination product. Support regulatory submissions, regulatory..

... Functions: Prepares documentation and submits regulatory filings including 510k submissions, Device ... registrations/CE mark. Coordinates with international regulatory team members on product changes ... members on product changes and..

Senior Director, Government Affairs & Policy Duties: Anticipate changes in the legislative, regulatory, policy, and political environments in the short, mid and long term, and advise senior leadership to inform business ..

Essential Functions: Plans and coordinates all aspects of internal information system-specific projects from initiation to delivery. Coordinates work performed by IT, Engineering, and operational staff and internal customers/partners by defining project ..

Essential Functions:Research, compile, and edit subject matter related to dental industry using PubMed, Google Scholar, and Cochrane databases; determines relevant datasets to extract and incorporate into literature.Creates Clinical Evaluation Reports (CER) ..

... for develop clinical, scientific, and regulatory documents while working in a ... Provide support with submissions to regulatory agencies by drafting clinical sections ... periodic safety updates to global..

Associate General Counsel, Regulatory Affairs The candidate will provide legal ... candidate will provide legal and regulatory advice and services on issues ... the organization. Will lead the Regulatory Affairs..