Bulgaria
Regulatory Affairs and Pharmacovigillance at stada
Pharmaceuticals
Education
Medical University Sofia, Faculty of Public health 2011 — 2012
Master, Health Management
Sofia University St. Kliment Ohridski 2002 — 2007
bachelor, Biology
Experience
stada pharma bulgaria Regulatory Affairs and PharmacovigillancestadaJune 2009 - Present
stada 2009 - 2013
STADA 2009 - 2011
Stada Pharma Bulgaria 2009 - 2011
Stada Pharma Bulgaria 2009 - 2011
Skills
CTMS, Generic Programming, Technology Transfer, Regulatory Affairs, Dossiers, Clinical Development, FDA, ANDA, Combination Products, Medical Writing, Pharmacovigilance, Regulatory Requirements, DCP, Oncology, CRO, Clinical Research, Dossier Preparation, CMC, Lifesciences, Drug Safety, GCP, Regulatory Documentation, Regulatory Guidelines, Pharmaceutical Industry, GMP, 21 CFR Part 11, eCTD, EMA, Sop, CAPA, Biotechnology, Orphan Drugs, CMC Regulatory Affairs, Regulatory Filings, Therapeutic Areas, Clinical Trials, Medical Devices, Change Control, Regulatory Submissions, NeeS, Electronic Submissions, ICH-GCP, ICH guidelines, Validation, Clinical Monitoring, NDA, IND, CTD, PMA, Pharmaceutics