Sr. VP, Regulatory Affairs & QA
Greater San Diego Area
Sr. VP, Regulatory Affairs & QA
Greater San Diego Area
(Biotechnology industry)
July 2008 — Present (4 months)
(Public Company; Pharmaceuticals industry)
October 2000 — February 2008 (7 years 5 months)
Regulatory interactions for all domestic and international filings; strategic advice for all projects; senior regulatory direction for the company; overseeing quality assurance including GMP, GCP, and GLP activities; overseeing medical writing, clinical drug safety (2000 until function was transferred to Clinical in 2003), and the scientific library; currently manage 22 professionals; started the department with 2 people, and grew to the current size over time.
(Public Company; 5001-10,000 employees; Pharmaceuticals industry)
May 1993 — October 2000 (7 years 6 months)
Initially started the GCP complaince group at Quintiles, which became their QA group. Then expanded into regulatory strategy and submissions.
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
October 1988 — May 1993 (4 years 8 months)
As manager : Full regulatory management of both marketed and investigational products. Regulatory handling of all aspects of a product from chemistry, manufacturing, and controls to advertising through both internal and external written and verbal correspondence. The products included non-steroidal anti-inflammatories and MDI beta-agonists and the divisions involved at FDA were the Pilot Drug Evaluation Unit and the Division of Pulmonary and Oncology Drugs.
As Associate Director: Responsibilities involved items of a regulatory nature that were not product specific. For example, site manufacturing changes, environmental assessment regulations, adverse experience reporting for investigational and marketed products, new HCFA legislation, international coordination with Basel headquarters and diastereomer development issues. The functions performed for these ranged from rendering a regulatory opinion to providing formal in-house training.
1974 — 1978