Anthony Joseph Diyenna

*** ********** *****

West Chester, PA 19380

yf24hi@r.postjobfree.com

610-***-****

Academic Training

MS, Villanova University Graduate School

Biology

BS, Villanova University

Biology with a Minor concentration in Religious Studies

Professional Experience

October 2011 – Present: Company Core Data Sheet Specialist

Pharma-Bio Serv, Inc., Plymouth Meeting PA

Currently on assignment at McNeil Consumer Healthcare in Fort Washington, PA

• Lead a cross-functional global team in the preparation of Company Core Data Sheets (CCDS) for OTC drug products and selection of Reference Safety Information documents to serve as core safety information in product labeling

• Review of label components for consistency with labeling information on file with FDA

January 2003-October 2011: Regulatory Affairs Manager

Pfizer Inc. / Wyeth Pharmaceuticals, Collegeville PA

• Provide expert regulatory leadership on R&D Nutritional Project Teams in accordance with team objectives.

• Interface with global colleagues to assess market-specific regulatory requirements and develop appropriate regulatory strategies.

• Regulatory support for the commercialization of new and currently marketed products across all regions, with main areas of focus being in Asia-Pacific, Latin America, and Middle East/ Africa regions.

• Author and maintain Regulatory Label Review SOP and Core Data Sheets for the Nutritionals business unit.

• Review of promotional materials for compliance with local regulations and Marketing Codes for children’s nutritional products.

• Proofreading of Medical Justification documents to support registration of new product innovations.

• Reach across functional groups in creating submissions for new ingredient authorizations in various countries.

• Responsible for training all global regulatory colleagues in corporate registration procedures.

• Develop talent by serving as a mentor to new colleagues in the Regulatory group.

October 1996-January 2003: Senior Regulatory Coordinator / Regulatory Coordinator

Wyeth Pharmaceuticals, St. Davids PA

• Regulatory support for the commercialization of new and currently marketed products across all regions, with main areas of focus being in Asia-Pacific, Latin America, and Middle East/ Africa regions.

• Review of promotional materials for compliance with local regulations and Marketing Codes for children’s nutritional products.

August 1988-October 1996: Clinical Data Associate / Clinical Data Assistant

Wyeth Pharmaceuticals, St. Davids PA

• Project Leader responsibilities for cardiovascular drug projects, providing assistance to other therapeutic area groups when required.

• Editing of clinical data from patient case reports for review by regulatory authorities.

• Preparation of monthly status reports.

• Mentoring and training of new colleagues in the department.

June 1986-July 1988: Editor

Biosciences Information Service (BIOSIS), Philadelphia PA

• Editing, indexing and proofreading of biological and medical abstracts for publication in globally accessed reference materials. .

December 1983-January 1986: Research Assistant / Quality Control Chemist

SEMEX Medical, Malvern PA

• Development of medical and cosmetic ingredients sourced from biologically-derived materials.

• Quality testing of finished products and management of QA laboratory.

• QA production auditing.

• Regulatory affairs assistance and preparation of Material Safety Data Sheets (MSDS) for all products.

June 1981-December 1983: Research Assistant

Norwood Industries, Malvern PA

• Development of textile and laminated adhesive products for medical and industrial applications.

Awards / Accomplishments / Special Training and Skills

• 2002: Responsible for the establishment of Wyeth Nutrition’s Climatic Zone IV stability testing program.

• 2003: Business Across Borders Cultural Awareness Program (Dean Foster Associates).

• 2004: Wyeth Nutrition Mission, Vision and Values Award for Quality.

• 2004: Leadership Training Program, Center for Creative Leadership.

• 2011: Currently pursuing training in Lean Six Sigma.

• Training and experience with CMC processes.

• Skilled and proficient in EDMS, GDMS, MS Word, Excel, PowerPoint and Adobe Acrobat.

Referrals

F. Owen Fields, Ph.D.,

Bio Therapeutics Regulatory Lead, Pfizer Inc.

129 Greenridge Road, Glenmoore PA 19343

484-***-**** (Bus.)

610-***-**** (Res.)

yf24hi@r.postjobfree.com

Jeanne M. Hoskin, Ph.D.,

Executive Director – Regulatory Affairs, Pfizer Nutrition

19 Maple Tree Drive

Westhampton, NJ 08060

609-***-**** (Res.)

yf24hi@r.postjobfree.com

Raymond J. Maggio

Senior Director, Wyeth Nutrition (Ret.)

809 Windemere Court, Conway SC 29526

843-***-**** (Res.)

Lynne L. Ziss

Associate Director, Wyeth Nutrition (Fmr.)

1644 Christine Drive, West Chester PA 19380

610-***-**** (Res.)

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