Regulatory Affairs Professional
Resume:
Anthony Joseph Diyenna
West Chester, PA 19380
*********@*******.***
610-***-**** (Res.)
484-***-**** (Mobile)
A regulatory affairs professional with 15+ years’ experience in areas including
CMC, facilitation of global regulatory submissions, regulatory strategy and review
of promotional materials for compliance with local legislation. Experienced in
providing regulatory leadership on commercialization teams. Proficient in
Enterprise Document Management as well as Microsoft Word, Excel, and
PowerPoint.
Professional Experience
June 2013 - May 2014: Regulatory Affairs Senior Associate
Accenture, Wayne PA
• Expert regulatory review of Structured Product Labeling (SPL) for
submission to FDA. Developed training materials and conducted SPL
training for the Regulatory Affairs group
• Utilized strong proofreading skills to perform QC of regulatory submissions
on behalf of pharmaceutical client companies
October 2011 – May 2013: Company Core Data Sheet Specialist
Pharma-Bio Serv, Inc., Plymouth Meeting PA
On assignment at McNeil Consumer Healthcare in Fort Washington, PA
• Led 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
Provided expert regulatory leadership on R&D Nutritional Project Teams in
accordance with team objectives
Evaluated proposed new product formulations for compliance with regulatory
requirements in European Union, Australia/New Zealand, Codex
Alimentarius and individual country regulations
Led a global cross-functional team convened to re-formulate the majority of
company's products in China, Pfizer Nutrition's largest market, in response
to new food regulations issued by the Chinese MOH in 2010. Deadlines
for all deliverables were met.
Assembled electronic submissions for product registration and license
renewal
Interfaced with global colleagues to assess market-specific regulatory
requirements and develop appropriate regulatory strategies
Collaborated with global regulatory affiliates to identify and address CMC
requirements for changes in product formulations, and launch of new
products, to meet targeted submission dates
Provided regulatory support for the commercialization of new and currently
marketed products (post-approval) across all regions, with main areas of
focus being in Asia-Pacific, Latin America, and Middle East/Africa regions
Authored and maintained Regulatory Label Review SOP and Core Data
Sheets for the Nutritionals business unit
Reviewed promotional materials for compliance with local regulations and
Marketing Codes for children’s nutritional products
Proofread Medical Justification documents to support registration of new
product innovations
Anthony Joseph Diyenna
990 Roundhouse Court
West Chester, PA 19380
*********@*******.***
610-***-**** (Res.)
484-***-**** (Mobile)
January 2003-October 2011: Regulatory Affairs Manager
Pfizer Inc. / Wyeth Pharmaceuticals, Collegeville PA (continued)
Reached across functional groups in creating submissions for new ingredient
authorizations in various countries
Responsible for training all global regulatory colleagues in corporate
registration procedures
Developed 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
Provided 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
Reviewed 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
Served as Project Leader for cardiovascular drug projects, providing
assistance to other therapeutic area groups when required
Edited clinical data from patient case reports for review by regulatory
authorities
Prepared monthly status reports
Mentored and trained new colleagues in Clinical Data Management
June 1986-July 1988: Editor
Biosciences Information Service (BIOSIS), Philadelphia PA
Edited, indexed and proofread biological and medical abstracts for publication
in globally accessed reference materials
Academic Training
MS, Villanova University Graduate School
Biology
BS, Villanova University
Biology with a Minor concentration in Religious Studies
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
Training and experience with CMC processes
Skilled and proficient in Documentum, GDMS, MS Word, Excel, PowerPoint
and Adobe Acrobat.
Contact this candidate