Manager Development

SILVIA B. BENDINER

Tel: 787-***-****

E- Mail: **************@*****.***

QUALIFICATIONS

-Fields of Expertise: pharmaceuticals, biotechnology, medical devices, translation stem cell therapy - USA and world markets.

-Consultant: Business Development, Strategic Planning, Licensing

-Director and General Manager of Operations: Clinical and Pre Clinical Trials at Site Management Organization and Clinical Research Organization (Mexico).

- Regulatory Affairs and Compliance – USA, Canada, Mexico, Europe, LATAM.

- Technical Translator and Interpreter: Pharmaceutical, Bio Sciences and related fields.

EMPLOYMENT HISTORY

2009 – present. Bendiner & Associates, Inc. Dorado, Puerto Rico.

Director: International Business Development and Licensing. Consultant to Bio Science firms searching for new business opportunities in the USA-Canada,Puerto Rico, Mexico and the Latin American territory.

2008 – 2009 Animal Cell Therapies and Stemedica Stem Cell Technologies.

San Diego, California. Consultant Regulatory Affairs and Business Development for cross boarder research and development project using human adult stem cells and animal stem cells. Set up the basis for the “ Mexico - Latin American - USA International Consortium Initiative” for stem cell research for the treatment of chronic neurodegenerative diseases in humans in collaboration with key opinion leaders in the field of neurosciences from Mexico and other Latin American countries.

2007 – 2008 Bendiner & Associates, Inc. Chula Vista, California, USA.

Director: International Business Development and Licensing Focused on the search, development and inception of new market opportunities throughout Mexico and the Latin American territory for a San Diego based importer of European – Italian gourmet products.

2004 – 2006 Bendiner & Associates, Inc.. Wilmington, Delaware, USA.

Director: International Business Development and Licensing. Bendiner & Associates, Inc. negotiated strategic alliances and partnering agreements between Mexican pharmaceutical outfits and Swiss-Canadian companies.

Agreements dealt with Supply and Distribution of generic oncology and HIV/AIDS products and a high-tech biotechnology compound.

2000 – 2003 Bendiner & Associates, Inc., Wilmington, Delaware, USA.

Partner: Clinical Research and Drug Development. From the Subsidiary Office in Mexico City, Bendiner & Associates, Inc. created a “Site Management Organization” (SMO) in alliance with national and international (European) drug researchers, universities, government institutions and clinical investigators. Professional efforts focused on organizing and executing Clinical Trials (Phases I-IV) on behalf of foreign pharmaceutical and device companies.

Therapeutic areas: Oncology, Urology, Infectious Diseases, Gastroenterology, Gynecology, among other specialties.

1997 – 2000 Bendiner & Associates, Inc. Wilmington, Delaware, USA

Consultant to pharmaceutical, biotechnology and medical device industries. Produced feasibility and market research studies for evaluating business opportunities in Mexico and Latin America. Developed and executed Regulatory strategies and prepared product registration dossiers (NDA’s) on behalf of various clients from Italy, Canada and Switzerland.

1995 – Debio Research Pharmaceutique S.A. Martigny, Switzerland

Manager, Business Development Responsible for the development and implementation of Regulatory strategies for an LHRH agonist across Latin America, the USA and Canada. Liaise between the Debio Headquarters and licensees in the Latin American territory. Executed Business Development, Marketing support, Sales Force training and Product Commercialization activities

1993 – Baxter Health Care Corporation, Evere, Bruxelles.

European Product Manager. European Product Management and Regional Marketing coordination activities for Italy and Spain with Financial Marketing responsibility: Regional 28 MM – European: 58MM

1992 - Independent Drug Regulatory Affairs- Milano, Italy.

Independent Consultant Technical/Scientific support for preparing IND’s and NDA’s (Pharmaceuticals and devices) for submission to Health Regulatory Agencies in the member States of the European Community.

1991- Studio Legale Globale Pelosi - Milano, Italy

Senior Account Manager. Business Development services through Italy. Job responsibilities dealt with Legal, Marketing and Integrated Communication consulting.

1987 – Farmitalia Carlo Erba – Milano, Italy International Regulatory Affairs Manager. USA, Canada, Central – South America, Europe and the Eastern European countries Supervised Regulatory personnel in 49 countries. Organized three Regulatory Affairs Congresses for the International Regulatory Affairs Professionals Society - IRAPS Congresses held in Hungary, Netherlands and France.

1986 – E. I. DuPont De Nemours & Co, Inc – Delaware, USA

Auditor, Good Laboratory Practices (GLP’s) Audited and inspected pre-clinical studies and the Toxicology Department for G.L.P compliance.(IND’s and NDA’s)

1984 – E. I. DuPont De Nemours & Co, Inc – Delaware, USA

Manager Regulatory Affairs - Latin America Responsible for the registration of pharmaceutical products on a worldwide basis with main emphasis on the Latin American Region. Extensive travel through the Latin American Region: Mexico, Venezuela, Colombia, Brazil and Argentina.

1982 – E. I. DuPont De Nemours & Co, Inc – Delaware, USA Training Specialist, Technical Translator and Simultaneous Interpreter.

Clinical and Instrument Systems Division. Trained Medical Technologists and Pathologists from the USA and abroad in the operation, maintenance and troubleshooting of the ACA®, Automatic Discrete Clinical Analyzer.

Translated and dubbed training materials in audiovisual format.

1981 – University of Delaware, Newark, Delaware-USA

Faculty Member: Full time faculty member in the Foreign Languages Department.

1975 – University of Buenos Aires, Argentina. Teaching Assistant. Held lectures and courses in Histology and Embryology. Published lecture notes for Veterinary Medicine students in Anatomy, Organic Chemistry and Biological Physics.

FOREIGN LANGUAGES.

Fluent in Spanish, English, German and Italian.

Complete understanding of oral and written Portuguese and French.

PROFESSIONAL AFFILIATIONS

American Society Clinical Oncology: 2000 – 2008

Societa de Immunoematologia e Trasfusione Del Sangue – Associazione Italiana Centri Trasfusionali;

1987- 1992 IRAPS International Regulatory Affairs Professional Society.

Board Member: held office for three years as Scientific Secretary.

EDUCATION

1978 –1980 University of Delaware, Delaware, USA. Bachelor of Arts and Sciences with special emphasis on the study of Simultaneous Translation and Interpretation from English into Spanish. Graduated with honors: Dean’s List

1975 – 1978 University of Buenos Aires, Argentina. Veterinary Medicine studies.

1971 – 1975 Colegio Lincoln, Buenos Aires, Argentina. Bilingual Bachelor in Letters and Sciences (High School).

Contact this candidate