Manager Management

RICHARD A. PEROTTI

*** ******* ***** ***** - ******** - CA 94044

650-***-**** ********@*******.***

________________________________________________________________________

REGULATORY AFFAIRS - REGULATORY OPERATIONS - CLINICAL REGULATORY

SUMMARY

Over 12 years Experience in Regulatory Affairs, Regulatory Operations and

Clinical Regulatory Affairs

with Pharmaceutical and Biotechnical products, including New Drug

Applications, Investigational New

Drug Applications, Clinical Trial Applications, Marketing Authorization

Applications and Dossier Preparation

PROFESSIONAL HISTORY

Regulatory Affairs Consultant 2009 -

Current

Consultant in Regulatory Affairs activities to the Pharmaceutical Industry

Current Clients: Medivation, San Francisco - OXiGENE, South San Francisco

Specializing in IND and CTA submissions, approvals and maintenance

Alzheimer's Disease - Huntington Disease - Prostate Cancer - Anti-Vascular

Drugs: Vascular

Disrupting Agents

Anesiva, Inc. Manager, Regulatory Affairs

2008 - 2009

South San Francisco, CA

Responsibilities included the preparation of drug submissions to FDA and

European Agencies including Investigational New Drug applications, Clinical

Trial Applications, Amendments, Annual Reports and Safety Reports.

Instituted new Clinical Trial Monitoring, Principal Investigator

Authorization and Drug Shipment Approval procedures that expedited the

approval of new Investigators and reduced paper file production. Updated

Regulatory SOPs to reflect and comply with current practices. Developed

Electronic Document Management Systems.

Therapies - Novel therapeutic treatments for pain, Needle free drug

delivery system

Chiltern International / CoGenesys, Inc. Manager, Regulatory Affairs

2007

Rockville, MD - Palo Alto, CA

Preparation of Investigational New Drug applications and Clinical Trial

Applications to FDA and European Agencies. Development and maintenance of

INDs including Amendments, Annual Reports and Safety Reports. Directed

Clinical Trial Monitoring and Drug Shipment Approval. Managed the

development of Regulatory SOPs.

Therapies - Type 1 and 2 Diabetes Mellitus - Treatment of Patients with

Heart Failure - Treatment of Infections Associated with Heart Failure

ALZA Corporation Manager, Regulatory Affairs & Operations

1997-2006

[A Subsidiary of Johnson & Johnson] Mountain View, CA

Responsible for tracking all company projects for Regulatory Affairs

Department and coordinating input from project team members. Management of

Regulatory Affairs' Operations Group

Preparation of IND and NDA new drug submissions to FDA including annual

reports, supplements and amendments. Team member in the development and

submission of five New Drug Applications including eNDAs.

Regulatory support and document management for international regulatory

filings; including the coordination of responses to questions from

regulatory authorities related to new NDA and MAA products.

Key responsibility for obtaining and maintaining Federal Registration of

Drug Establishment/Labeler Code Assignments and State Drug and Device

Manufacturing licenses. Management of Johnson & Johnson's Operations Group

within Regulatory Affairs Department for submission of documents to

Agencies and partners. Assisted with the preparation and maintenance of

Standard Operating Procedures and Material Safety Data Sheets pertaining to

department functions.

Management of budget for Regulatory Affairs' Operations Group, vendor

contracts for internal Document Scanning and Publishing Systems and

external document scanning and printing. Coordinated litigation data

disclosures and document preparation for Legal Department and Management of

Data Disclosure relating to Mergers and Acquisitions. Coordinated product

development tracking meetings, including Research and Development,

Marketing, Sales, Management, Purchasing and Manufacturing.

Therapies - Oncology, Urologic, Pain, ADHD - Specializing in Drug Delivery

Systems: E-TRANS, D-TRANS, Inserts, Controlled Release Tablets, Micro-

Abrasion

Perotti & Associates - Pacifica, CA Consultant

1995 - 1997

Direct Product Development and Environmental Protection Agency interaction

for Agribusiness Companies

The Scotts Company - Marysville, OH Director, Regulatory Affairs

1989 - 1994

Grace-Sierra Crop Protection Company - Milpitas, CA

Management of worldwide Regulatory Affairs activities for Multinational

Corporation in Crop Protection, Nursery and Lawn & Garden areas

EDUCATION

Bachelor of Arts Degree, Marketing - San Francisco State University

Associate in Arts Degree, Chemical Technology - San Francisco City College

CONTINUING EDUCATION

Review of Practices, Policies and ICH Guidelines Specifications

Managing Multiple Projects - Project Management

Controlled Substances - Overview of Drug Development

Good Manufacturing Practices Awareness - Basic Training Course on Drug

Development

Introduction to International Regulatory Affairs & Strategies

Expert Reports for European Marketing Applications

Supervising for Safety - Managing Conflict in the Workplace - General

Safety Training

Unlawful Harassment Prevention - Quality Orientation - Focus on GXPs -

Foreign Corrupt Practices Act

Effective Workplace Communication - Change Management

Adverse Event Reporting for Marketed Products - Responding to FDA

Investigations

MILITARY SERVICE

United States Army - Vietnam Era Veteran

PROFESSIONAL REFERENCES SUBMITTED UPON REQUEST

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