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Senior Director Of Quality And Regulatory Affairs Jobs

Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Director, Us Medical Affairs, Patient Access, And Quality Of Care (Paq) – Oncology Solid Tumor Strategy
By Gilead Sciences At , Foster City
Effective organizational, project planning, and time management skills. Strong sense of urgency and goal orientation
Assist with management of PAQ Medical Affairs Advisory Programs (MAAPs)
Extensive knowledge of the US healthcare ecosystems, payer landscape and payer evidence requirements
Excellent strategic thinking skills, with demonstrated ability to successfully lead the ideation, development of a plan and move to action
Solid working knowledge of regulatory and compliance environment
Professional written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
Director Of Quality And Regulatory Affairs; Full Time; Days
By Mount Sinai At , New York, 10029 $140,000 - $230,584 a year
Responsible for supporting the management of an operating budget for the department.
Maintains current knowledge of quality improvement information, patient safety, and regulatory requirements.
Coordinates all documentation requirements for the Performance Improvement and National Patient Safety Goal chapters of The Joint Commission manual.
Supports the coordination and direction all activities to ensure the effective implementation of the Quality Improvement Plan.
Designs, develops, implements and evaluates quality improvement policies and procedures.
Develops and facilitates the use of data collection tools to support data analysis.
Director Of Regulatory & Quality/ 监管与质量保证总监
By Medical Instrument Development Laboratories At , San Leandro, 94577 $160,000 - $180,000 a year

Position Title: Director of Regulatory Affairs and Quality Assurance

Director/Senior Director Regulatory Affairs
By RBW Consulting At United States
7-10+ years Regulatory Affairs experience
Experience in development and commercial product lifecycle (Phases 1-3, Marketed Products)
Relevant experience with regulatory applications (IND / CTA / NDA / MAA etc.)
Success in filing IND's/CTA's in Oncology
Educated (MSc, PhD, or PharmD) in the Life Science, Pharmacy or similar field.
Direct exposure to FDA/EMA etc. Interactions
Director Of Quality And Regulatory Compliance Rn
By KA Recruiting, Inc. At Lewisburg, WV, United States

DIRECTOR OF QUALITY & REGULATORY COMPLIANCE NEEDED IN WEST VIRGINIA full time, permanent position extremely competitive pay excellent benefits bachelor"s required registered nurse certification ...

Senior Director Of Quality And Regulatory Affairs
By Goodall Brazier At Texas, United States
12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.
Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Regulatory Knowledge CBER, CDER, CDRH, and other global agencies
Experience interacting with FDA and other global agencies
Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements
Experience leading a Quality Dept at a CDMO (preferred)