Gdansk, Pomeranian District, Poland
Senior Regulatory Affairs Specialist at Polpharma SA
Staffing and Recruiting
Experience
ZF Polpharma SA September 2003 - Present
Skills
Drug Safety, Validation, NeeS, Cleaning Validation, CRO, Regulatory Submissions, GMP, FIFRA, Regulatory Documentation, Change Control, CMC, Regulatory Requirements, DMF, Biotechnology, Chemistry, Lifesciences, PowerPoint, Technology Transfer, GLP, Formulation, Pharmaceutical Industry, GxP, Regulatory Affairs, GCP, Outlook, Quality Assurance, Generic Programming, Microsoft Office, 21 CFR Part 11, ICH-GCP, IND, V&V, Analytical Chemistry, Drug Development, CTD, CMC Regulatory Affairs, Biopharmaceuticals, Clinical Development, ICH guidelines, Clinical Research..., Computer System..., MHRA, Pharmaceutics, Quality Auditing, Pharmacovigilance, Sop, NDA, eCTD, Microsoft Excel, Clinical Trials