Manager of Quality Assurance and Regulatory Affairs Jobs

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1-15 of 256 Jobs
Alvogen, Inc - Morristown, NJ
Stays informed of FDA and ICH Guidelines related to GMP (Commercial & Development)....
1 day ago
HireMinds LLC - Boston, MA
team interactions with agency contacts Review and prepare clinical protocols, investigator brochures, informed consents, and other GCP documentation with internal teams You will drive drafting of clinical...
1 day ago
Humacyte - Research Triangle Park, NC
trial applications; Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License (BLA) Applications and Marketing Authorization Approvals (MAAs) Interpret FDA (and other...
1 day ago
Beacon Hill Staffing - Baltimore, MD
General knowledge of the drug/vaccine development process or clinical trials is a plus. Experience in preparing regulatory documents, publishing regulatory submissions using?...
1 day ago
Revance Therapeutics, Inc. - Newark, CA
trial materials....
18 hours ago
GlycoMimetics, Inc. - Rockville, MD
Provides support, guidance, and oversight for clinical studies and requires a focus on compliance with Good Clinical Practice (GCP) regulations and guidance documents....
18 hours ago
Amri Incorporated - Rensselaer, NY
Manager, Quality Assurance AMRI QA - Quality Control, Supply Chain, Inventory Rensselaer New York 12144 click here to apply report this job Manager, Quality Assurance Job Description Manager,...
1 day ago
Bicycle Therapeutics plc - Lexington, MA
development functional areas including preclinical, clinical, regulatory affairs and manufacturing are desired Highly collaborative, strong relationship building skills with high level of integrity...
4 hours ago
Hikma Pharmaceuticals - Berkeley Heights, NJ
The candidate should have comprehensive knowledge of regulatory guidelines and statutes including: CFR, FDA & ICH Guidelines, FDA Recommended BE Drug Product Specific Guidance, and USP compendia general...
1 day ago
Covance Incorporated - Morrisville, NC
. * Regulatory knowledge of Submission/registration types and requirements of GxPs (GCPs, GLPs, GMPs) Preferred: * Experience with drug development, FDA, EMA, and ICH guidelines * Experience in regulatory...
14 hours ago
Daiichi Sankyo, Inc. - Basking Ridge, NJ
Provide leadership and direction based on assigned programs and in close collaboration with Head of QA R&D to ensure that the organization is in a perpetual state of compliance. Ensure strategic...
18 hours ago
Kelly Services - Nashville, TN
Associate Director of Quality Assurance (Direct Hire) - Nashville, TN Reporting to the Director of Quality, the Associate Director of Quality Assurance will be responsible for oversight of...
9 hours ago
Novavax - Gaithersburg, MD
ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial....
9 hours ago
BioMarin Pharmaceutical Inc. - San Rafael, CA
Description BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target...
6 hours ago
Wuxi - Austin, TX
Excellent knowledge of ICH/GCP. Excellent written and oral communication skills with internal/external teams and customers....
5 hours ago

Manager of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities

Healthcare Finance, Economics and Risk
This course is part of the Healthcare Administration MicroMasters program which consists of 7 courses and a capstone exam. After completing the program, you can also apply to Doane University to...

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