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Online Resumes with "Global Regulatory Submissions"



Scientist- 14 years-Chicago

I am a R&D Pharmaceutical Microbiology scientist, supporting new products development and marketed products, developing and validating microbiology methods, FDA and global regulatory submissions, gap assessments and remediation, VPP site R&D safety Chair, Write Lab investigation and CAPA.

Clinical Regulatory Affairs - 13 Years of Experience - Near 19711

My background includes 13 years’ experience in the Pharmaceutical Industry at AstraZeneca Pharmaceuticals in Global Regulatory Submissions and Life Cycle Management of Regulatory documents. This includes 6 years’ experience as a Project Manager for Regulatory Global submissions. As a Project manager within the Submission Management Group, I provided expertise on global submission compilation and published electronic submiss...

Tags for this Online Resume: Newark, DE, Life Cycle Management, Regulatory Global Submissions, Pharmaceutical Industry, RSS Application, eCTD Publisher, electronic submissions, Regulatory Publisher, Management, Cardiovascular, Document Management, Legal, Pharmaceutical, Project Management, Publishing, Quality Assurance

Director

QUALIFICATIONS: Over twenty years drug development experience ranging from pre-clinical pharmacology / toxicology to managing and directing clinical and cross functional teams in the conduct and execution of global, clinical trials. Experience includes coordinating and planning for budgeting, resourcing, drug supply, site and sponsor audits, and global regulatory submissions. Management experience includes management of in-...

Tags for this Online Resume: Data Management, Management, Nephrology, Clinical Research, Clinical Study Reports, Drafting, Oncology, Project Management, Project Manager, Protocol