Regulatory Program Director at Genentech
San Francisco Bay Area
BioMarin Pharmaceutical Inc.
Senior Manager Regulatory Affairs
May 2015 to Present
San Francisco Bay Area
Senior Manager of Regulatory Affairs
July 2013 to April 2015
Senior Regulatory Affairs Associate
December 2010 to June 2013
Senior Research Associate II
June 2007 to November 2010
Schering-Plough Research Institute
July 2005 to June 2007
Advanced Research Associate
November 2002 to July 2005
ChemRX Advanced Technologies
Research Associate II
August 1999 to November 2002
What company does Azim Celebi work for?
Azim Celebi works for BioMarin Pharmaceutical Inc.
What is Azim Celebi's role at BioMarin Pharmaceutical Inc.?
Azim Celebi is Senior Manager Regulatory Affairs
What industry does Azim Celebi work in?
Azim Celebi works in the Pharmaceuticals industry.
• Proven solid scientific track record with 11 patents and publications and combined 15 years of applied research, discovery, lead development, and regulatory CMC experience. • US RAC certified by Regulatory Affairs Professionals Society (RAPS). • Experience in global filing strategy, assessment, and implementation of initial filings and various post-approval changes. • Have a broad understanding of pharmaceutical manufacturing, change control and global distribution systems. • Strong problem solving skills with ability to handle multiple tasks simultaneously and adapt to changing priorities. • In relation to pharmaceutical and device industry, in-depth working knowledge of US, EU, Canadian, and Australian regulations, ICH guidance/regulations, cGMPs, 21 CFRs, USP-NF, Ph.Eur., eCTD, and especially local laws such as Sherman Food, Drug, and Cosmetic Law. • Experience in the US import & export issues for commercial and clinical products. • Experience in leading and collaborating in fast-paced, team-oriented cross-functional teams. • Knowledge of regulatory compliance principles, including participation in agency inspections. • Strong understanding of pharmaceutical industry from drug discovery to post marketing activities of marketed products. • In-depth knowledge of eCTD and life-cycle management. • Ability to work independently with minimal supervision. • Self-starting, detail oriented, and ability to focus. • Excellent technical writing, communication, and presentation skills.Senior Manager Regulatory Affairs @ From May 2015 to Present (8 months) San Francisco Bay AreaSenior Manager of Regulatory Affairs @ From July 2013 to April 2015 (1 year 10 months) Senior Regulatory Affairs Associate @ From December 2010 to June 2013 (2 years 7 months) United StatesSenior Research Associate II @ From June 2007 to November 2010 (3 years 6 months) Associate Scientist @ From July 2005 to June 2007 (2 years) Advanced Research Associate @ From November 2002 to July 2005 (2 years 9 months) Research Associate II @ From August 1999 to November 2002 (3 years 4 months)
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
2 year(s), 4 month(s)
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