Angel Rodriguez

Angel Rodriguez Lathrop, CA

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Work:

Green Thumb Lawn Care
Manteca, CA
Jun 2012 to Nov 2012
Landscaper California fleet service
Lathrop, CA
Nov 2011 to Jun 2012
Trailer Mechanic

Education:

Angel Rodriguez

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Work:

The Hope Chest
Modesto, CA
Sep 2011 to Dec 2011
Stocked Shelves, unloaded cars, cashier Bell Passi Baseball Snack Bar
Modesto, CA
Mar 2008 to Jul 2008

Education:

Enochs High School
May 2012
English Modesto Junior College
Spanish

Angel Rodriguez Clovis, CA

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Work:

Education:

Angel Rodriguez O'Fallon, MO

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Work:

Self Employed

Feb 2009 to 2000
INDEPENDENT REGULATORY SCIENCE CONSULTANT KV PHARMACEUTICAL COMPANY
St. Louis, MO
Jul 1999 to Feb 2009
Regulatory Affairs Director

Education:

Skills:

Regulatory Affairs Preparation and review of ANDAs, NDAs, INDs, DMFs, amendments, supplements, annual reports, state licensing, product listing, facility registration. Familiar with e-CTD format including preparation and review of Quality Overall Summary. Direct interaction with FDA (Office of immunologic and anti-infective, office of generic drugs). European regulatory requirements. Latin America and Canada submission experience. Regulatory Strategic Assessment. Regulatory intelligence. Technical/Regulatory/Medical Writer - Hands on experience writing/editing manufacturing batch records, analytical methods, validation protocols/reports, stability protocol/reports, expert reports, product development reports, clinical protocols, clinical final reports, periodic safety reports. Labeling - Target product profile, initial and post approval, maintenance, international, promotional, advertising Experienced Manager Training. Oversight and follow up of activities. Performance coaching / appraisal. Staffing. Project management. Analytical Chemistry Chromatography. Spectrophotometry. Dissolution. Wet chemistry. Development and validation of analytical methods. Preparation and review of stability reports. Quality Operations cGMPs. Audits (master batch records, analytical raw data). Out of specification investigations. Non-conformance reports. Process deviation assessment. Change control procedures. Standard operating procedures. CAPA. Exception reports. FDA inspection management (principal escort and support group). Annual reviews. Manufacturing Operations Granulation (fluid bed, spray dried, high / low shear, direct compaction, extrusion / spheronization). Coating (beads, tablets). Blending. Unit dosing (compression / encapsulation / soft gel capsules). Oral liquids. Suspensions. Sterile (small volume parenterals, emulsions). Powders (for reconstitution, topicals). Semisolids (creams, ointments, gels, patches). Packaging Operations Qualification of container / closure systems. Oversight of packaging operations (solids, liquids and semisolids). Technical Services Generation, execution and review of process validation, IQ, OQ and PQ protocols. Process optimization / trouble shooting. Technology transfer (from R&D to production). Generation of master batch records, analytical methods, specifications. Product Development Reverse engineering. Formula and process design. IIG. Quality overall summary. Product development reports. Establishment of specifications. Qualification of raw materials. Strategic Assessment Due diligence. Product evaluation (technical, regulatory). International submissions. Intellectual property (evaluation of prior art, patent disclosures, development of paragraph IV strategies). Internet based research. Clinical Development Preliminary design of clinical trials (type of studies, clinical end points, patient population). Clinical study audits. CRO selection process. Evaluation of bio lab procedures. Language Fully bilingual (Spanish English). Can read and translate documents from Portuguese.